Unfallkrankenhaus Berlin September 3, 2016

Dr. med. Leonhard Bruch
leonhard.bruch@ukb.de
030/5681 3601
Berlin

Medizinische Hochschule Hannover September 3, 2016

PD Dr. med. Julian Widder
widder.julian@mh-hannover.de
0511/532 -3841
Hannover

Percutaneous Ventricular Restoration (PVR) therapy using the Parachute® Device in Patients with Ischemic Dilated Heart Failure: PARACHUTE III, European Post Market Trial, 2 Year Results July 21, 2016

TCT 2015 Parachute III – 2 Year Euro PostDr. Ulrich Schäfer, The Heart Center at the University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany

Percutaneous Ventricular Restoration (PVR) therapy using the Parachute® Device in Patients with Ischemic Dilated Heart Failure: PARACHUTE III, European Post Market Trial, 2 Year Results

Percutaneous Ventricular Restoration (PVR) therapy using the Parachute® Device in Subjects with Ischemic Dilated Heart Failure: Two Year Pooled-Analysis July 21, 2016

TCT 2015 Parachute – 2 Year Pooled-Analysis Dr. Karl-Heinz Kuck, ASKLEPIOS Klinik St. Georg, Hamburg, Germany

Percutaneous Ventricular Restoration (PVR) therapy using the Parachute® Device in Subjects with Ischemic Dilated Heart Failure: Two Year Pooled-Analysis

CardioKinetix Announces the 500th Parachute Heart Failure Device Implantation July 21, 2016

Menlo Park, Calif. – July 21, 2016— CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced that 500 patients have received  the company’s Parachute® Ventricular Partitioning Device for heart failure. Patients have been treated in more than 15 countries, including patients in key international markets where the device is commercially available, and patients enrolled in PARACHUTE IV, the company’s U.S. pivotal trial under investigational device exemption (IDE).

After a heart attack, many patients experience enlargement of the left ventricle. This enlargement causes a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath, fatigue, swelling in the legs, ankles and feet, rapid or irregular heartbeat, and reduced ability to exercise. Treatment options for patients whose ventricle has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment designed to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

“Heart failure is a large area of fast-growing unmet need, both clinically and from a health economics perspective,” said Dr. Abraham. “Patients with heart failure suffer from debilitating symptoms and have few effective treatment options, and the results to date in the Parachute studies are very encouraging. It is important for the medical community to collaborate in completing this pivotal study to further the treatment options for heart failure patients.”

“With more than 500 patients now treated with the Parachute device in 15 countries, and a growing body of clinical data supporting the therapy, we feel we have made tremendous progress toward establishing this minimally invasive device as a promising alternative for patients with heart failure,” said Maria Sainz, president and CEO of CardioKinetix.

Clinical data supporting the use of the Parachute device has been published in 35 peer-reviewed journals. Two-year safety and efficacy results from 100 European patients treated with the Parachute device were presented at the annual Transcatheter Cardiovascular Therapeutics (TCT) conference in October 2015.

The company’s U.S. pivotal study, PARACHUTE IV, a large-scale, multi-center, randomized trial, is presently enrolling patients at over 70 treatment centers in the United States. The trial is more than 50% enrolled and is led by three National Principal Investigators, Drs. William Abraham (Ohio State University Medical Center), Marco Costa (Case Western Reserve University), and Leslie Saxon (University of Southern California), leaders in the fields of heart failure, interventional cardiology and electrophysiology, respectively. The trial leadership illustrates the multi-disciplinary approach of the Parachute therapy, common among novel structural heart therapies.

About Heart Failure:

Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected.

About the Parachute® Ventricular Partitioning Device:

The Parachute device is designed to offer the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. The procedure is performed in the catheterization laboratory under limited sedation. Clinical data has demonstrated improved overall cardiac function and quality of life for patients treated with the Parachute device.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale. Currently CardioKinetix is enrolling an IDE study in the U.S. (clinicaltrials.gov identifier NCT01614652).

About CardioKinetix Inc.:

CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by U.S. Venture Partners, Tekla Healthcare Investors (NYSE:HQH), Tekla Life Sciences Investors (NYSE:HQL), SV Life Sciences, Panorama Capital, New Leaf Venture Partners, Lexington Private Equity, and Edwards Lifesciences.

For more information please visit www.cardiokinetix.com.

 

CardioKinetix contact:

Nicole Osmer

650-454-0504

nicole@nicoleosmer.com

TX- Texas Cardiac Arrhythmia Research Foundation April 18, 2016

Austin, Texas, United States, 78745

Contact: Deb Cardinal, 512-458-9410, dscardinal@austinheartbeat.com

Principal Investigator: John Dieck, MD

Principal Investigator: Rodney Horton, MD

TN- Wellmont Holston Valley Medical Center April 18, 2016

Kingsport, Tennessee, United States, 37660

Contact: Brandy Venable, 423-230-5618, BVenable@mycva.com

Principal Investigator: Christopher Metzger, MD

Principal Investigator: Freddie Williams, MD

NE- Nebraska Heart Hospital April 18, 2016

Lincoln, Nebraska, United States, 68526

Contact: Corey Godfrey, 402-328-3930, cgodfrey@neheart.com

Principal Investigator: Steven Martin, MD

Principal Investigator: Gina Mentzer, MD

KY- St Joseph Hospital/Kentucky One April 18, 2016

Lexington, Kentucky, United States, 40504

Contact: Shannon Hibbits, 859-313-4161, shannonhibbitts@catholichealth.net

Principal Investigator: Nezar Falluji, MD

Principal Investigator: Michael Schaeffer, MD

KY- Baptist Health Lexington April 18, 2016

Lexington, Kentucky, United States, 40503

Contact: Feather Wafford, 859-260-6066, feather.wafford@BHSI.COM

Principal Investigator: Gery Tomassoni, MD

CT- Yale New Haven Hospital April 18, 2016

New Haven, Connecticut, United States, 06510

Contact: Christina Williams,  203-737-6407, Christina.Williams@yale.edu

Principal Investigator: Michael Cleman, MD

Principal Investigator: Lavanya Bellumkonda, MD

Principal Investigator: Joseph Akar, MD

Principal Investigator: Jude Clancy, MD

AZ- Arizona Heart April 18, 2016

Phoenix, Arizona, United States, 85013

Contact: Courtney Rothwell, 602-456-2342, crothwell@azheartrhythm.com

Principal Investigator: Vijendra Swarup, MD

University of Aachen March 29, 2016

PD Dr. Reith
Aachen, Germany

Universitätsklinik Erlangen March 14, 2016

Prof. Achenbach
Erlangen, Germany

Universitätsklinik Köln March 14, 2016

PD Dr. Rudolph
Köln, Germany

UKSH Campus Lübeck March 14, 2016

Prof. Thiele
holger.thiele@uksh.de
0451/500-2501
Lübeck, Germany

Universitäres Herzzentrum, Universitätsklinik Eppendorf March 14, 2016

PD Dr. Schäfer
u.schaefer@uke.de
040 7410 – 53979
Hamburg, Germany

CardioKinetix Announces US Pivotal Trial More Than Half Enrolled January 14, 2016

Menlo Park, Calif. – January 14, 2016— CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced that it has enrolled more than half of the subjects in its pivotal United States trial, PARACHUTE IV. The trial is evaluating the innovative Parachute device for the treatment of patients suffering from heart failure, a highly debilitating condition.

After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath, fatigue, swelling in the legs, ankles and feet, rapid or irregular heartbeat, and reduced ability to exercise. Treatment options for patients whose ventricle has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

Dr. William Abraham from the Ohio State University, Dr. Marco Costa from University Hospitals, Case Western Reserve University, and Dr. Leslie Saxon from the University of Southern California provide physician leadership for the trial. A multidisciplinary approach similar to other novel structural heart therapies is optimal for success. The Parachute Heart Team leverages heart failure, interventional cardiology and electrophysiology experts to identify patients with ischemic etiology and reduced ejection fraction for enrollment.

“As a physician, I am often frustrated that there is not more that I can do for my patients with heart failure following a heart attack to improve debilitating symptoms,” said William Abraham, M.D., professor of internal medicine and director of the Division of Cardiovascular Medicine at Ohio State University Medical Center. “The Parachute is an innovative device that holds promise as a breakthrough treatment that could transform quality of life for these patients.”

“We are pleased to have reached this milestone in the US trial, and are looking forward to completing the enrollment phase. We are very excited with the interest in our therapy from interventional cardiologists, heart failure specialists and electrophysiologists,” said Maria Sainz, president and CEO of CardioKinetix. “This achievement was accomplished by the strong partnerships with our more than 60 clinical sites.”

About Heart Failure
Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected.

About the Parachute® Ventricular Partitioning Device
The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. The procedure is performed in the catheterization laboratory under limited sedation. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

The Parachute Ventricular Partitioning Device received CE Mark in 2011.  In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale. Currently CardioKinetix is enrolling an IDE study in the U.S. (clinicaltrials.gov identifier NCT01614652).

About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by U.S. Venture Partners, Tekla Healthcare Investors (NYSE:HQH), Tekla Life Sciences Investors (NYSE:HQL), SV Life Sciences, Panorama Capital, New Leaf Venture Partners, Lexington Private Equity, and Edwards Lifesciences.

For more information please visit www.cardiokinetix.com.

 

CardioKinetix contact:
Barry Templin
650-364-7016
btemplin@cardiokinetix.com

MD – University of Maryland Medical Center December 18, 2015

Baltimore, Maryland
Contact: Joanne Marshall 410-328-8790, jmarshal@medicine.umaryland.edu
Principal Investigator: Mukta Srivastava, MD
Principal Investigator: Gautam Ramani, MD
Principal Investigator: Timm-Michael Dickfeld, MD

CA – University of Southern California (USC) December 18, 2015

Los Angeles, California
Contact: Melissa Minor 323-442-7983, melissa.minor@med.usc.edu
Principal Investigator: Rahul Doshi, MD
Principal Investigator: David Shavelle, MD
Principal Investigator: Andrew Yoon, MD

CardioKinetix Announces South Korean Approval 
for the Parachute System for Heart Failure October 13, 2015

Menlo Park, Calif. — CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced that it has received regulatory approval for the Parachute® System in South Korea by the Korean Ministry of Food and Drug Safety (MFDS).

After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

“We are pleased to have received approval for the Parachute device, and are excited to introduce the therapy to patients with heart failure in South Korea,” said Maria Sainz, president and CEO of CardioKinetix. “The achievement of this milestone builds upon the technology adoption we are experiencing in the Asia market where we have treated the first 100 patients, completed a Chinese clinical trial, and recently received regulatory approval in Indonesia.”

About Heart Failure
Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected.

About the Parachute® Ventricular Partitioning Device
After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output, which results in heart failure symptoms such as shortness of breath. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. The procedure is performed in the catheterization laboratory under limited sedation. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

The Parachute Ventricular Partitioning Device received CE Mark in 2011.  In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale. Currently CardioKinetix is enrolling an IDE study in the U.S. and Canada (clinicaltrials.gov identifier NCT01614652).

About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by U.S. Venture Partners, Tekla Healthcare Investors (NYSE:HQH), Tekla Life Sciences Investors (NYSE:HQL), SV Life Sciences, Panorama Capital, New Leaf Venture Partners, Lexington Private Equity, and Edwards Lifesciences.
For more information please visit www.cardiokinetix.com.

CardioKinetix contact:
Barry Templin
650-364-7016
btemplin@cardiokinetix.com

NC – Wake Forest Baptist Health July 24, 2015

Winston-Salem, North Carolina
Contact: Amanda Morgan 336-713-4432, asmorgan@wakehealth.edu
Principal Investigator: David Zhao, MD
Principal Investigator: Ebere Chukwu, MD

KS – University of Kansas July 24, 2015

Kansas City
Contact: Melissa Jaeger, 913-588-9627 ,  mjaeger@kumc.edu
Principal Investigator: Mark Wiley, MD
Principal Investigator: Randall Genton, MD
Principal Investigator: Dhanunjaya Lakkireddy, MD

Principal Investigator: Madhu Reddy, MD

MA – Tufts Medical Center July 24, 2015

Boston, Massachusetts
Contact: Ryan O’Kelly 617-636-4990, rokelly@tuftsmedicalcenter.org
Principal Investigator: Navin Kapur, MD
Principal Investigator: David Denofrio, MD

MI – Mid Michigan Medical Center July 24, 2015

Midland, Michigan
Contact: Jamie Prior 989-631-2469, jamie.prior@midmichigan.org
Principal Investigator: Andrzej Boguszewski, MD
Principal Investigator: Michael Lauer, MD

CardioKinetix Announces Excellent Results of Chinese Trial Evaluating Parachute Heart Failure Device March 24, 2015

Menlo Park, Calif. and Beijing, China — CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced three-month clinical and echocardiographic results of PARACHUTE China, a study of 31 Chinese patients treated consecutively with the company’s Parachute® Ventricular Partitioning Device.

“The results of this study, which met its primary and secondary endpoints, continue to substantiate the safety profile and effectiveness of the Parachute as a viable minimally invasive ventricular partitioning device for patients with ischemic heart failure,” said Gao Runlin, M.D, chief cardiologist at Fu Wai Hospital, Chinese Academy of Medical Sciences, and co-principal investigator of the trial, who presented the results at the China Interventional Therapeutics (CIT) 2015 conference in Beijing. “The very compelling data from these Chinese patients demonstrates the clear promise of this breakthrough technology and is consistent with previous data reported from Europe and the United States.”

The primary endpoint of left ventricular end systolic volume index (LVESVi) reduction as compared to baseline was met by a reduction from 78.2±20.3 ml/m2at baseline to 53.4±17.4 ml/m2 at three-month follow-up, which was found to be highly significant (p < 0.0001). The three-month highlights from the data include:

• Very high procedural success rate of 97 percent
• Secondary Safety Endpoint: Device or Procedure Related MACE rate of 3 percent
• Secondary Efficacy Endpoints Achieved
o NYHA functional class improved from 2.1 to 1.4 (p < 0.001)
o EQ5D VAS Score improved from 64 to 76 (p < 0.01)
• Hemodynamic Improvement
o Ejection Fraction improved from 29.8% to 36.1% (p < 0.0001)
o Wall Motion Severity Index improved from 2.6 to 2.0 (p < 0.0001)
o Stroke Work indexed to End Diastolic Volume improved from 29.4 mmHg to 35.9 mmHg (p < 0.001)

“The PARACHUTE China trial is the fourth trial to demonstrate statistically and clinically meaningful results from our clinical program. The achievement of meeting the primary and secondary endpoints of the China study is a major milestone for CardioKinetix,” said Maria Sainz, president and CEO of CardioKinetix. “We are highly encouraged by the Chinese investigators’ enthusiasm for the Parachute device where already more than 50 patients have been treated through clinical trials or special access programs from nine hospitals. The Parachute can address a significant unmet need in the care of heart failure patients in China.”

About PARACHUTE China
PARACHUTE China (clinicaltrials.gov/NCT02240940) enrolled NYHA II to ambulatory IV ischemic heart failure patients with ejection fraction 15-40% to support the regulatory submission for the Parachute device to the China Food and Drug Administration (CFDA). The primary endpoint of the study is reduction in left ventricle end systolic volume index (LVESVi) at three months, which was analyzed at an echocardiography core lab, Yale Cardiovascular Research Group.
The principal investigator is Gao Runlin, M.D, Chief Cardiologist, Fu Wai Hospital, Chinese Academy of Medical Sciences. Huo Yong, M.D., director of the Heart Center and Department of Cardiology PKU-1st Hospital, and president, Chinese Society of Cardiology, and Yang Yuejin, M.D., Ph.D., vice president of Cardiovascular Institute and Fu Wai Hospital, serve as co-principal investigators.

About Heart Failure
Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected.
About the Parachute® Ventricular Partitioning Device
After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output, which results in heart failure symptoms such as shortness of breath. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. The procedure is performed in the catheterization laboratory under limited sedation. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.
The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by U.S. Venture Partners, Tekla Healthcare Investors (NYSE:HQH), Tekla Life Sciences Investors (NYSE:HQL), SV Life Sciences, Panorama Capital, New Leaf Venture Partners, Lexington Private Equity, and Edwards Lifesciences.
For more information please visit www.cardiokinetix.com.

CardioKinetix contact:
Barry Templin
650-364-7016
btemplin@cardiokinetix.com

CardioKinetix Completes Enrollment in Chinese Trial of First-of-Its-Kind Parachute Device for Treatment of Heart Failure January 8, 2015

Menlo Park, Calif. — CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced the completion of enrollment in PARACHUTE China, a multi-center trial to evaluate the minimally invasive Parachute® Ventricular Partitioning Device for the treatment of heart failure.

Results of PARACHUTE China will be presented at the China Interventional Therapeutics (CIT) 2015 conference, which will take place March 19-22 in Beijing, China.

“The completion of enrollment in the China study is a major milestone for CardioKinetix,” said Maria Sainz, president and CEO of CardioKinetix. “We are highly encouraged by the Chinese investigators’ enthusiasm for the Parachute device and commitment to enrolling the trial so efficiently, and we look forward to releasing the results this spring.”

PARACHUTE China (clinicaltrials.gov/ NCT02240940) enrolled NYHA II to ambulatory IV ischemic heart failure patients with ejection fraction 15-40% to support the regulatory submission for the Parachute device to the China Food and Drug Administration (CFDA). The primary endpoint of the study is reduction in left ventricle end systolic volume index (LVESVi) at three months, which will be analyzed at an echocardiography core lab, Yale Cardiovascular Research Group.

The principal investigator is Gao Runlin, M.D, Chief Cardiologist, Fu Wai Hospital, Chinese Academy of Medical Sciences. Huo Yong, M.D., director of the Heart Center and Department of Cardiology PKU-1st Hospital, and president, Chinese Society of Cardiology, and Yang Yuejin, M.D., Ph.D., vice president of Cardiovascular Institute and Fu Wai Hospital, serve as co-principal investigators.

About Heart Failure
Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected.

About the Parachute® Ventricular Partitioning Device
After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output, which results in heart failure symptoms such as shortness of breath. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. The procedure is performed in the catheterization laboratory under limited sedation. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by U.S. Venture Partners, Tekla Healthcare Investors (NYSE:HQH), Tekla Life Sciences Investors (NYSE:HQL), SV Life Sciences, Panorama Capital, New Leaf Venture Partners, Lexington Private Equity, and Edwards Lifesciences.

For more information please visit www.cardiokinetix.com.

 

CardioKinetix contact:
Barry Templin
650-364-7016
btemplin@cardiokinetix.com

CardioKinetix Completes $50 Million Financing and Signs Agreement with Edwards Lifesciences, Including Exclusive Option to Purchase December 9, 2014

Menlo Park, Calif. — CardioKinetix, Inc., a medical device company pioneering a catheter-based treatment for heart failure, announced today that it has completed a $50 million financing led by Edwards Lifesciences Corporation, with participation from existing investors U.S. Venture Partners, Tekla Healthcare Investors (NYSE:HQH), Tekla Life Sciences Investors (NYSE:HQL), SV Life Sciences, Panorama Capital, New Leaf Venture Partners, and Lexington Private Equity.

CardioKinetix has also entered into an agreement that provides Edwards Lifesciences the right to acquire CardioKinetix based on future regulatory milestones.

This financing provides the company with the capital necessary to complete the PARACHUTE IV randomized pivotal clinical trial of the Parachute® Ventricular Partitioning Device for the treatment of heart failure. Data from the study, which is currently enrolling patients in the United States, will be the basis for the company’s pre-market approval (PMA) submission to the U.S. Food and Drug Administration (FDA). The financing will also enable CardioKinetix to pursue international market development efforts in key geographies.

“We are very proud of our accomplishments to date, with more than 300 patients treated, four clinical trials completed and 23 publications on the Parachute therapy,” said Maria Sainz, president and CEO of CardioKinetix. “Heart failure remains a huge global clinical and economic challenge for healthcare systems, and Parachute holds the promise to bring needed improvements in mortality, quality of life, and care efficiency to clinical providers. We are pleased to have the support of Edwards Lifesciences and our premier investor syndicate as we further our efforts to complete the PARACHUTE IV trial and bring the Parachute therapy to patients around the world.”

Cooley LLP served as legal counsel to CardioKinetix.

About Heart Failure
Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected.[i]

About the Parachute® Ventricular Partitioning Device
The novel Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device. Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under limited sedation.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by U.S. Venture Partners, Tekla Healthcare Investors (NYSE:HQH), Tekla Life Sciences Investors (NYSE:HQL), SV Life Sciences, Panorama Capital, New Leaf Venture Partners, Lexington Private Equity, and Edwards Lifesciences.
For more information please visit www.cardiokinetix.com.

Media contact:
Nicole Osmer
650-454-0504
nicole@nicoleosmer.com

[i] Heart disease and stroke statistics – 2012 update: a report from the American Heart Association. Circulation 2012; 125: e2-e220.

RI – The Miriam Hospital November 24, 2014

Providence, Rhode Island
Contact: Catherine Gordon, RN, BSN 401-793-4105, cgordon@lifespan.org
Principal Investigator: Paul Gordon, MD
Principal Investigator: Daniel Levine, MD

TN – Saint Thomas West Hospital November 24, 2014

Nashville, Tennessee
Contact: Judy McCarthy , 615-222-3862, judith.mccarthy@sth.org
Principal Investigator: Andrew Morse, MD
Principal Investigator: Don Chomsky, MD

FL – Florida Hospital Tampa – Pepin Heart Institute November 6, 2014

Tampa, Florida
Contact: Cynthia Paysor, LPN, CCRC 813-615-7527, cynthia.paysor@ahss.org
Principal Investigator: Charles R Lambert, MD

Congestive Heart Failure 101 October 28, 2014

Congestive heart failure affects nearly 5 million Americans, yet many do not understand what congestive heart failure exactly is or how to treat it. To combat that unintended ignorance, we’ve put together your complete congestive heart failure 101 guide.

Congestive heart failure (CHF), simply put, occurs when the heart is not able to pump out enough blood. When the heart is receiving enough blood but cannot pump it out adequately, it literally becomes congested with blood, which backs up behind the heart. This can quickly become fatal, both because of lack of blood flow to the body and because of the dangers of this backup itself.

treating heart disease

There are different multiple types of CHF. The heart is made up of two pumps, one on the left side and one on the right, and either one of the pumps can fail independently of one another. When the left side fails, blood begins to back up into the lungs because the lungs are located behind the left side of the heart. This causes fluid in the lungs and shortness of breath. When the right side fails, blood backs up into the blood veins and capillaries throughout the body and leaks out into surrounding tissue. This causes swelling predominantly in the lower body.

Causes

Many things can cause CHF, with the most two most well-known factors being a congenital disposition toward heart failure, in which the risk of CHF is inherited, and high blood pressure, which forces the heart to work harder than it should have to. There are many other potential causes including disease of the heart valves, leaky valves, an overactive thyroid, unusual heart rhythms, anemia, or even an infection of the heart valves.

The three most common factors of heart disease include:

Coronary Artery Disease – A disease in the arteries that supply blood and oxygen to the heart, causing decreased blood flow to the heart muscle.

Previous Heart Attack – Heart attacks cause severe damage to the heart muscle, which results in scarring that causes effected areas function poorly or not at all.

Cardiomyopathy – Infections, drug use, alcohol abuse, and other poor health choices can result in serious damage to the heart muscle.

Poor lifestyle patterns can also greatly increase the risk of CHF, including but not limited to obesity, bad cholesterol levels, smoking, drinking, and a lack of regular exercise.

CardioKinetix Initiates Study in China of First-of-Its-Kind Parachute Device for Treatment of Heart Failure October 24, 2014

Menlo Park, Calif. – CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced the enrollment of the first patients in PARACHUTE China, a multi-center trial to evaluate the minimally invasive Parachute® Ventricular Partitioning Device for the treatment of heart failure.

The first ten patients were treated with the Parachute device in Beijing at Peking University and Fu Wai Hospital, and in Shanghai at Shanghai Tenth People’s Hospital.

Gao Runlin, M.D, Chief Cardiologist, Fu Wai Hospital, Chinese Academy of Medical Sciences, principal investigator of the trial, said, “I am thrilled to be pioneering this exciting therapy in China with my colleagues, where there is a significant need for better treatments for heart failure. I am very proud that the first clinical trial cases were performed last week with such high interest by the study investigators, building upon the early, positive experience with the Parachute by leading cardiovascular centers in China.”

PARACHUTE China (clinicaltrials.gov/ NCT02240940) will enroll NYHA II to ambulatory IV ischemic heart failure patients to support the regulatory submission for the Parachute device to the China Food and Drug Administration (CFDA). The primary endpoint of the study is reduction in left ventricle end systolic volume index (LVESVi) at three months, which will be analyzed at an echocardiography core lab, Yale Cardiovascular Research Group. Other key endpoints include functional outcomes, quality of life, and hemodynamic measures by echocardiography. Huo Yong, M.D., director of the Heart Center and Department of Cardiology PKU-1st Hospital, and president, Chinese Society of Cardiology, and Yang Yuejin, M.D., Ph.D., vice president of Cardiovascular Institute and Fu Wai Hospital, serve as co-principal investigators.

“The initiation of the China study is a major milestone for CardioKinetix,” said Maria Sainz, president and CEO of CardioKinetix. “We are proud of our efforts to bring the Parachute technology to market on three continents. The initiation of the China trial, along with the active enrollment in our PARACHUTE IV U.S. pivotal trial and the initial commercialization in key European centers under CE Mark, illustrate our commitment to developing the Parachute therapy for heart failure globally.”

After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output, which results in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged and who suffer from heart failure are limited, with a significant number currently receiving an implantable cardioverter-defibrillator (ICD) and many a cardiac resynchronization therapy device (CRT-D) device. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

About Heart Failure
Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected.

About the Parachute® Ventricular Partitioning Device
The novel Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under limited sedation.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Archer Ventures, Panorama Capital, H&Q Healthcare Investors (NYSE:HQH), and H&Q Life Sciences Investors (NYSE:HQL). For more information please visit www.cardiokinetix.com.

 

CardioKinetix contact:
Barry Templin
650-364-7016
btemplin@cardiokinetix.com

What Is the Difference Between Left- and Right-Sided Heart Failure? October 22, 2014

We often discuss heart failure as if it is a single type of phenomenon. In reality, the two sides of the heart can fail independently of each other, and each event has its own causes and effects. So what is the difference between the two?

Understanding how the Heart Works

To see the difference between heart failure on the left and right side, it’s important to understand where the heart is located and how it works. The heart has two jobs: to collect returning, “used” blood and pump it into the lungs to be enriched with oxygen, and to take oxygen-rich blood from the lungs and pump it out to the rest of the body. The heart’s left and right sides are each responsible for one of these two crucial jobs.

Prevention and treatment of heart failure

We often think of the heart as being located in the center of the chest, but in reality the heart sits off slightly to the left side. This is the ideal position to allow it to do both its jobs. From this location, the left side of the heart is close to the top of the left lung, and this placement determines the respective jobs of the left and right ventricles of the heart.

The left ventricle is by far the larger of the two halves of the heart, because it does the difficult job of pumping blood out to the entire body. It draws the blood from the left lung where it has been filled with fresh oxygen. The pumping of this side of the heart sends the blood out to all the body’s organs and extremities, which need the oxygen to live and work.

As oxygen is depleted from the blood, it returns to the heart on the right side. The right ventricle pumps the blood back to the lungs to start the process over. Both the left and right ventricles‘ jobs are necessary for people to live—and either or both can be interrupted by heart failure.

Causes of Heart Failure

Heart failure occurs when one or both sides of the heart have difficult pumping (or difficulty relaxing between pumps). This can be caused by many things, from a blood clot or heart attack to congenital factors. However, heart failure has different effects, depending on which side it strikes.

In left-sided heart failure, the heart can no longer adequately bring in fresh blood from the lung and pump it out to the body. This causes blood to back up and pool in the left lung. Shortness of breath, heaviness in the chest and difficulty breathing are common signs of left-sided heart failure.

Right-sided heart failure often occurs in response to left-sided failure. The right ventricle becomes overworked and fails in turn. If right-sided heart failure occurs on its own, blood returning from the body becomes backed up.

Both versions of heart failure are extremely serious and need to be treated immediately. The earlier that heart failure treatment is administered, the more likely it is that the patient can survive and recover.

Four Reasons To See A Cardiologist October 8, 2014

In a brief overview, a cardiologist is a doctor who specializes in diagnosing and treating diseases or conditions associated with hearth and blood vessels. Generally speaking, people will be referred to a cardiologist if they have a serious heart condition that threatens their livelihood. Here are four possible common heart symptoms you should immediately visit your cardiologist over:

Four Common Traits of Serious Heart Conditions

1. Chest pain is one of the classic symptoms of an impending heart attack. According to the CDC, approximately 720,000 Americans have a heart attack each year. Of those, 515,000 people experience their first attack and the remaining have had one previously. Those numbers may shock you; however, if you experience chest pains, it’s best to visit a cardiologist who can pinpoint the issue. Heart-related chest pain stems around the left-center side of the chest and it’s described as though an elephant is sitting directly on your chest.

2. Consistent coughing can be a symptom of heart failure which could be due to fluid accumulation in the lungs. Bloody phlegm while coughing is also a further sign that an immediate visit to a cardiologist is needed.
Cardiologits can help treating heart disease
3. Irregular or rapid pulse can be associated with heart attacks, heart failure or an arrhythmia. If it’s left untreated, it can lead to a stroke or even sudden death. Accompanying those symptoms with weakness, dizziness, or shortness of breath can provide more evidence that there is a problem with the heart’s function.

4. Shortness of breath from above can be a serious indicator by itself as a warning of heart problems. This could be a symptom of cardiomyopathy, which is a disease of an abnormal heart muscle that makes it more difficult for your heart to pump and deliver blood to the rest of your body.

Seek medical attention immediately if you experience any of the above symptoms as your life could be at risk. Every 33 seconds someone in the United States dies from cardiovascular disease so being as proactive can save your life. Be sure to check in with your heart doctor regularly!

A Second Chance at Life Given with the Parachute September 26, 2014

Richard Murphy was making funeral arrangements at age 40. His heart was in bad health following a heart attack and his prognosis was not looking optimistic.

All hope was not lost; however, scared of “wasting away on the couch,” Richard went to the internet and found the Parachute. Seeing it as a viable option, Richard underwent the operation with Flordia Hospital Pepin Heart Institute’s Dr. Charles Lambert’s help.

Following the successful implementation of the Parachute, Richard’s life “was transformed.” With his new heart health, he is celebrating better heart health…as well as a new child on the way!

Watch the video on Richard’s inspiring story below!

Sentara Heart Specialists are Utilizing the Parachute IV September 19, 2014

Over on Sentara News’ website, they profiled Sentara Heart specialists utilizing the Parachute IV as a new method for treating congestive heart failure. Sentara News profiled how the Parachute is placed inside the heart using minimally invasive heart catheterization and can block damaged heart muscle and “reshape the organ to prevent further progression of chronic heart failure.”

Click read more below to see the Parachute in action!

‘Parachute’ could lift quality of life for heart failure patients September 18, 2014

Video and article from Fox News about how the ‘Parachute’ could lift quality of life for heart failure patients.

View the full article here.

KANSAS CITY, Mo. Fox News 4 Kansas City — Wayne Linhardt, a heart patient, has high hopes over something called Parachute.

“I want to breathe better. I want to have energy to do a few things,” said Linhardt.

The Lincoln, Missouri man has heart failure from a heart attack decades ago. His left ventricle enlarged and stiffened over time, putting pressure on the rest of the heart. That causes fatigue and life-threatening rhythms.

“He’s been shocked by his defibrillator many times because the rest of the heart is so irritable because of this extra pressure,” said Dr. Andrew Kao, Linhardt’s cardiologist.

At Saint Luke’s Mid-America Heart Institute, Linhardt became the first patient in our area, and the 52nd in the country to get the experimental device called Parachute. No open heart surgery was necessary. Dr. Adnan Chhatriwalla threads catheters from the groin up to the heart. He places an anchor device for the parachute. A little balloon is used to open the parachute, and then it’s hooked to heart muscle. The parachute closes off the stiff part of the heart, preventing blood from pooling there.

“So the healthy tissue is able to work with less strain so it’s sort of like lifting 100 pounds before. Now you’re lifting 50 pounds,” said Dr. Kao.

A computer lottery determines which patients in the study get the device and which get standard medical therapy. The study will see if Parachute can slow the progression of heart failure, prevent hospital stays, and improve survival and quality of life.

“I want to be able to go fishing. I want to be able to travel,” said Linhardt.

A parachute could make it possible.

Risks include bleeding and infection. But the procedure could be less risky than open heart surgery to cut out the bad tissue. Previously, that was the only option for some people with this type of heart failure.

For more information on the study, CLICK HERE.

Heart Treatment Options September 16, 2014

Want to learn about two paths of heart treatment options?

Did You Know?
• Over 6 million people live with heart failure in the US, more than 20 million worldwide
• More than 600,000 new heart failure patients are diagnosed each year in the US
• Most are unaware how to treat congestive heart failure

Options for treating heart failure

 

Heart Health 101

How well do you know you heart? Cardiovascular health should always be a top priority when it comes to your well being. Regardless of your age, taking care of your heart can provide numerous benefits. Some steps you can begin taking today is eating healthy food, exercising and cutting back on bad habits like smoking. Cardio Kinetix understands the importance of heart health and wants to make sure you have the most information about cardiovascular health!

Click here to read the rest of our blog.

 

 

CardioKinetix Releases One-Year Clinical Data from European Trial Showing Consistent, Compelling Positive Results for Patients Treated with Minimally Invasive Device for Heart Failure September 15, 2014

Analysis from 100 Consecutive Post-Market Patients Presented at TCT and HFSA 2014 Substantiate Potential of Breakthrough Treatment for Heart Failure Patients

Menlo Park, Calif. — CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced results of a pooled analysis study of the first-of-its-kind catheter-based Parachute® Ventricular Partitioning Device. Twelve-month clinical data from PARACHUTE III, a study of 100 post-market European patients with ischemic heart failure treated consecutively between 2011 and 2013, were presented at the 2014 TCT Conference in Washington, D.C., by Ulrich Schäfer, M.D., cardiology director of the Structural Heart Division at the Heart Center at the University Medical Center Hamburg-Eppendorf, and at the 2014 HFSA Conference in Las Vegas, Nev., by William Abraham, M.D., professor of internal medicine and director of the Division of Cardiovascular Medicine at Ohio State University Medical Center.

“The results of this European post-market study continue to substantiate the safety profile and effectiveness of the Parachute as a viable, minimally invasive device technology for patients with heart failure,” said Dr. Abraham. “The very compelling data from these 100 European patients demonstrates the clear promise of this breakthrough technology and is exciting news for the more than 50 active hospitals in the U.S. randomized trial, PARACHUTE IV, which is currently enrolling patients.”

Parachute had a very high procedural success rate of 97 percent (97/100). The twelve-month highlights from the data include:

  • Primary safety endpoint yielded a low 7% rate of device- or procedure-related MACCE
  • Sustained reduction of left ventricle volumes (p < 0.0001) resulting in significant improvements in systolic function and a significant reduction in left atrial volume (p < 0.05) reflected improved diastolic function
  • NYHA functional class improved or maintained in 80 percent of patients
  • Six-minute walk distance improved at follow-up (p < 0.01), with 46 percent of patients walking an additional 20 meters or more
  • Rates of death and the combined endpoint of death and repeat hospitalization for heart failure were 9.5 percent and 26.0 percent, respectively

“The results of this trial add excitement about the Parachute treatment, which offers an option to heart failure patients with a very poor prognosis the promise for improved quality of life and reduced rates of mortality and heart failure hospitalization,” said Dr. Schäfer.

After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output, which results in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged and who suffer from heart failure are limited, with a significant number currently receiving an implantable cardioverter-defibrillator (ICD) and approximately one-third receiving a cardiac resynchronization therapy device (CRT-D) device. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

About Heart Failure
Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]

About the Parachute® Ventricular Partitioning Device
The novel Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Archer Ventures, Panorama Capital, H&Q Healthcare Investors (NYSE:HQH), and H&Q Life Sciences Investors (NYSE:HQL). For more information please visit www.cardiokinetix.com.

 

CardioKinetix contact:
Barry Templin
650-364-7016
btemplin@cardiokinetix.com

 

IA – University of Iowa Hospitals and Clinics September 4, 2014

Iowa City, Iowa
Contact: Page Scovel, RN, BSN 319-384-8005, page-scovel@uiowa.edu
Principal Investigator: Philip Horwitz, MD
Principal Investigator: Vladimir Cotarlan, MD

Why Are 1 in 4 Women Dying of Heart Disease? August 4, 2014

Heart disease affects both men and women; however, women face special risks that are different from those men face. At present, 1 out of every 4 women will die of heart disease. This includes left ventricle heart failure, one of the two main kinds of heart attack, which many people wrongly associate with men only. So why are so many women facing heart disease, with such a high risk rate?

There are a number of factors that contribute to the risk of left ventricle heart failure and heart disease, and many are common to men and women, such as high blood pressure, high “bad” cholesterol, obesity, smoking, heavy drinking, lack of exercise and congenital factors. But there are also risk factors that apply specifically to women. These include cultural factors, such as men being more encouraged to play sports and get exercise. But they also include simple misinformation. Since heart disease is thought of as a man’s disease, women who are having a heart attack often don’t realize it. They may attribute the symptoms to something else. Thus, treatment is delayed if it’s sought at all, which can be a fatal misjudgment.

That means it’s important for women to know the symptoms of a heart attack, which are more subtle that what we often see in movies or on TV. Symptoms of heart attacks in women include:

Pain in the neck, jaw, back or even the abdomen. This pain may not be the sudden shooting pain we associate with heart attacks. It may or may not be accompanies by chest pains. But it should always be taken seriously and heart attack should be considered as a possible culprit.
Nausea and vomiting. Sudden nausea is often explained away in women, but when there is no apparent cause it should be taken seriously.
Pain in the right arm.
Shortness of breath. Sometimes this precedes the full heart attack and often it lasts throughout the event. If breathness is short for no apparent reason, it’s a serious sign.
Sudden fatigue, when there is no reason to be fatigued.
Dizziness or lightheadedness.

Obviously, these symptoms can mean other things besides left ventricle heart failure. But when several of these symptoms happen together, it can mean a heart attack. A woman may not fall dramatically to the ground clutching her chest, but bear the subtle symptoms more quietly. When any of these symptoms are present, it’s always best to speak up and seek help immediately.

Source: Mayo Clinic (http://www.mayoclinic.org/diseases-conditions/heart-disease/in-depth/heart-disease/art-20046167)<

5 Foods That Help with Congestive Heart Failure July 28, 2014

How do you treat congestive heart failure? Once physicians have done their job, much of the work is up to you. That means eating a heart healthy diet that will reduce the strain on your heart and help prevent a dangerous situation. If you’re wondering where to start, here are five heart healthy and delicious foods to use as a cornerstone:
Left ventricle heart failure
1. Fresh fruits and vegetables. This item is easily the most important one on the list. Fresh fruits and veggies—especially the veggies—are crucial to a healthy diet for a number of reasons, but when you’re facing congestive heart failure they become even more important. A diet heavy in plants helps the heart in many ways: they’re rich in good cholesterol. They are not only low in bad cholesterol, but help lower the level of bad cholesterol in your system. They can help reduce blood pressure. Vegetables are low in calories and can help overcome obesity. And they are rich in antioxidants that help purge the system of free radicals. Green veggies are best, but fruits and vegetables of all kinds are heart healthy.
2. Oatmeal. Want something more filling than greens? Oatmeal is a great way to go. Oatmeal is among one of the few grain products that is considered heart healthy. It’s high in fiber, which again helps improve your cholesterol levels and reduce blood pressure. And it’s packed with Omega-3 fatty acids and other heart healthy nutrients.
3. Salmon. Salmon and other deep sea fatty fish are very hearth healthy. They make a great alternative to red and white meat because they are packed with more Omega-3 fatty acids than just about any food. And bought frozen, salmon steaks are surprisingly affordable. Consider a nice grilled salmon fillet the next time you want a big dinner.
4. Almonds and walnuts. This one’s a two-fer. Both almonds and walnuts are terrific additions to a heart healthy meal (such as a big green salad or a bowl of oatmeal, right?) and both for similar reasons; they’re high in fiber, a great source of protein without red meat, and deliver healthy mono- and polyunsaturated fats. Plus they’re tasty!
5. Red wine—in moderation. When doctors started to recommend red wine for heart health, it was big news. This one is often misunderstood however. While red wine is loaded with reservatrol, which in turn is rich in antioxidants, excessive drinking has serious risks for heart health. One glass is plenty for improving your cholesterol.

Of course, diet alone won’t treat congestive heart failure. But working closely with your physician and following all doctor instructions, a heart healthy diet can make a huge difference.

Source: WedMD (http://www.webmd.com/food-recipes/features/25-top-heart-healthy-foods)

Tasty Foods for a Heart Healthy Diet July 24, 2014

A heart healthy diet and exercise can reduce your risk of heart disease and help heart failure treatment, but in today’s society people are always on the move and many tend to eat unhealthy foods based primarily on convenience. With our busy lifestyles, some people feel they do not have enough time in their day to take a break and cook a healthy meal. While unhealthy foods, such as processed or fast foods, may seem more convenient, they are rich in saturated and trans fats, calories, sodium, cholesterol, and added sugars. Not to worry, though, there are countless easy-to-make and delicious foods that you can “grab on the go” while still promoting a healthy heart.

A key to a healthy diet is to eat more nutrient-rich foods in place of other unhealthy foods. The American Heart Association suggests eating more fruits and vegetables, eating more whole-grain foods, using liquid vegetable oils such as olive, canola, corn, or safflower as your main kitchen fat, and eating more chicken, fish, and beans over meats like beef, pork, or lamb. It also warns consumers to pay attention to nutrition labels, which can sometimes be misleading, to ensure they are getting the necessary nutrients. To maintain your cardiovascular health, here’s a list of some healthy yet tasty foods to incorporate into your diet.

Berries

 

Berries are great for your heart because they are rich in antioxidants, polyphenols, and other vital nutrients and can be easily incorporated in any meal, such as a salad, yogurt or fruit smoothie. Blueberries, for instance, contain fiber and Vitamin C and little to no sugar and fats. Studies show they also help your memory and widen your arteries to help blood flow.

Fish

Fish — particularly fatty or oily fish like salmon and tuna — is another delicious food that is great for your heart. Nutritionists recommend eating two servings of fish per week because they contain omega-3 fatty acids, which help lower triglyceride levels in the blood that lead to blood clotting and cause heart attacks. Fish also helps lower your blood pressure and prevent irregular heart rhythms.

Walnuts

Walnuts and many other nuts also contain omega-3 fatty acids, as well as unsaturated or “good” fats, fiber, Vitamin E, and plant sterols which help lower your cholesterol and improve the health of your arteries and heart. They are also delicious, convenient, and easy-to-store.

Heart failure (HF) imposes one of the highest disease burdens of any medical condition in the world with an estimated 23 million patients experiencing HF. Heart failure is also one of the most resource-intensive conditions with direct and indirect costs in the United States estimated at $39.2 billion in 2010. The overall mortality and readmission rates for heart failure continue to remain unacceptably high even with the array of available drugs, devices, and/or surgical techniques.

CardioKinetix provides treatment for heart disease. CardioKinetix developed a novel transcatheter implant called the Parachute® Ventricular Partitioning Device (Parachute). The Parachute intends to treat heart failure resulting from a heart attack in patients worldwide by improving overall cardiac function.

GA – Emory University Hospital Midtown July 11, 2014

Atlanta, Georgia
Contact: Jennifer Ro 443-204-3523, jcro@emory.edu
Principal Investigator: Gautam Kumar, MD

GA – Emory University Hospital July 3, 2014

Atlanta, Georgia
Contact: Lauren Wheeler, 404-712-7623, lmwheeler@emory.edu
Principal Investigator: Divya Gupta, MD
Principal Investigator: Kreton Mavromatis, MD

IL – Evanston Hospital July 3, 2014

Chicago, Illinois
Contact: Lisa Smalley 847-570-2366 lsmalley@northshore.org
Principal Investigator: Ted Feldman, MD
Principal Investigator: Steve Smart, MD

PA – University of Pennsylvania July 3, 2014

Philadelphia, Pennsylvania
Contact: Judi Willhide, judi.willhide@uphs.upenn.edu
Principal Investigator: Howard Herrmann, MD
Principal Investigator: Joyce Wald, MD

VA – Inova Fairfax Hospital July 3, 2014

Falls Church, Virginia
Contact: Perry Montgomery 703-776-6007, perry.montgomery@inova.org
Principal Investigator: Shawn Yazdani, MD
Principal Investigator: Desai Shashank, MD
Principal Investigator: Chirag Sandesara, MD

OK – Integris Baptist Medical Center July 3, 2014

Oklahoma City, OK
Contact: Miki Thompson, miki.thompson@integrisok.com
Principal Investigator: George Chrysant, MD
Principal Investigator: Douglas Horstmanshof, MD

ID – Kootenai Heart Clinics July 3, 2014

Coeur d’Alene, Idaho
Contact: Shamela Barnett, SBarnett@kh.org
Principal Investigator: Ronald Jenkins, MD
Principal Investigator: Tim Lessmeier, MD

PA – Lancaster General Hospital July 3, 2014

Lancaster, Virginia
Contact: Heidi Testa, hltesta@lghealth.org
Principal Investigator: Rupal Dumasia, MD
Principal Investigator: Justin Roberts, DO

TX – Memorial Hermann July 3, 2014

Houston, Texas
Contact: Nazanin Zarinkamar, nazanin.zarinkamar@uth.tmc.edu
Principal Investigator: Biswajit Kar, MD
Principal Investigator: Sriram Nathan, MD

NY – New York Presbyterian Hospital – Cornell Campus July 3, 2014

New York, New York
Contact: Melissa Ricketts, mdr2001@med.cornell.edu
Principal Investigator: Shing-Chiu Wong, MD
Principal Investigator: Evelyn Horn, MD

IL – Northwestern Memorial Hospital July 3, 2014

Chicago, Illinois
Contact: Leah Brousalis, 312-926-9874, LBROUSAL@nmh.org
Principal Investigator: Charles Davidson, MD
Principal Investigator: Allen Anderson, MD

LA – Ochsner Clinic July 3, 2014

New Orleans, Louisiana
Contact: Cristine Hardy, chardy@ochsner.org
Principal Investigator: Stephen Jenkins, MD
Principal Investigator: Hector Ventura, MD

OH – Riverside Methodist Hospital July 3, 2014

Columbus, Ohio
Contact: Martha Slyman 614-566-1274, martha.slyman@ohiohealth.com
Principal Investigator: Steven Yakubov, MD
Principal Investigator: Lee Jordan, MD

MO – St. Luke’s Hospital MAHI July 3, 2014

Kansas City, Missouri
Contact: Jackie Smith, jnsmith@saint-lukes.org
Principal Investigator: Andrew Kao, MD

IN – St. Vincent Heart Center July 3, 2014

Indianapolis, Indiana
Contact: Regina Margiotti, 317-338-6151, ramargio@stvincent.org
Principal Investigator: James Hermiller, MD
Principal Investigator: Mary Walsh, MD

TX – Methodist Hospital July 3, 2014

Houston, Texas
Contact: Patricia Brinegar 713-363-7995, pbrinegar@houstonmethodist.org
Principal Investigator: Neal Kleiman, MD
Principal Investigator: Jerry Estep, MD
Principal Investigator: Miguel Valderrabano, MD

MN – United Heart and Vascular Clinic July 3, 2014

St. Paul, Minnesota
Contact: Abbey Arndt , 651-241-2811,  abbey.arndt@allina.com
Principal Investigator: Bilal Murad, MD
Principal Investigator: Alan Bank, MD

AZ – University of Arizona July 3, 2014

Tucson, Arizona
Contact: Sobedya Lizette Marquez 520-626-5431, marquez@shc.arizona.edu
Principal Investigator: Ranjith Shetty, MD
Principal Investigator: Mark Friedman, MD

UT – University of Utah July 3, 2014

Salt Lake City, Utah
Contact: Ashlee Rooks 801-585-7295, ashlee.rooks@hsc.utah.edu
Principal Investigator: Anwar Tandar, MD
Principal Investigator: James Fang, MD

TN – Vanderbilt July 3, 2014

Nashville, Tennessee
Contact: Carol Meish 615-343-4983, carol.meisch@vanderbilt.edu
Principal Investigator: Robert Piana, MD
Principal Investigator: Daniel Lenihan, MD

IL – Advocate Health and Hospitals July 2, 2014

Chicago, Illinois
Contact: Joan Yanz, joan.yanz@advocatehealth.com
Principal Investigator: Mark Goodwin, MD
Principal Investigator: Maria Costanzo, MD

PA – Allegheny General Hospital July 2, 2014

Pittsburgh, Pennsylvania
Contact: Kenneth Rayl 412-359-6860, kray@wpahs.org
Principal Investigator: Dave Lasorda, MD
Principal Investigator: Srinivas Murali, MD

NJ – Deborah Heart and Lung Center July 2, 2014

Browns Mills, New Jersey
Contact: Lisa Cruser, 609-893-5028 ext 5028, CruserL@Deborah.org
Principal Investigator: Richard Kovach, MD
Principal Investigator: Mark Moshiyakov, MD

A New Heart Treatment for People with Heart Failure June 17, 2014

The Facts of Heart Failure

Few people are aware of the details behind congestive heart failure and what separates it from other forms of heart related failure. To start, coronary artery disease occurs when there is a blockage within the arteries that supply life-sustaining blood to the heart. This blockage can occur for several reasons, such as a narrowing of the arteries from calcium and cholesterol build up, artery inflammation, and blood clots. This can result in a “myocardial infarction”, which is more commonly referred to as a “heart attack”.

Comparatively, congestive heart failure is a type of cardiovascular disease that causes the diminished ability of the heart to pump blood properly or regularly fill the heart with blood. Congestive heart failure can result from a heart attack, but also from a history of high blood pressure or other related cardiovascular troubles. Additionally, fluid will begin to collect within the lungs, which can cause severe breathing issues.

The Parachute Heart Treatment Solution

The Parachute can partition the damaged muscle, separating the segment of muscle that no longer works from that which does. The Parachute implant is what is known as a form of percutaneous ventricular restoration, or PVR, therapy. After suffering from a heart attack, many patients will experience their left ventricle becoming enlarged. This causes a decrease in cardiac output, and can lead to further complications. For more information, click here.

How to Treat Heart Failure June 17, 2014

Heart failure treatment varies depending on the severity of the condition. Lifestyle changes are the primary treatment for all forms and levels of heart failure. As soon as you make healthy changes, the sooner you will feel better. To combat heart failure, attempt the following lifestyle changes to get one step closer to winning the fight.

Nutritious Diet for Your Heart

A heart healthy diet helps manage heart failure. If you ignore your condition and eat unhealthy foods, you could worsen your condition. Ask your doctors about what type of eating plan would work best for you. Fruits, vegetables, whole grains, fat-free or low-fat dairy products and lean meats are most likely the foods you will be recommended to eat. The overall healthy diet for heart failure treatment is low in sodium and low in sugar.

Load up on foods rich in potassium to counteract the heart failure medicines you are sure to be taking. These medicines, while necessary for your heart, lower the potassium body’s levels. Lack of potassium can lead to rapid heart rhythms. Yet too much is not beneficial either. Talk with a doctor to find the perfect balance of potassium for you. Potassium rich foods are spinach, bananas, white beans and sweet potatoes.

Fluids for Your Heart

Those with heart failure must pay special attention to their fluid intake. A necessary balance is necessary with your diet as well as fluids. Too much fluid for heart disease patients makes heart failure worse yet your body needs a certain amount of fluid to stay hydrated. Do not drink alcohol if you have heart failure. Discuss with your medical team, what your optimal fluid intake should be.

Exercise Daily to Treat Heart Failure

The best way to counteract heart failure is to become as physically fit as possible. Since your heart is in a precarious state, you must talk with a medical professional to find a safe and effective way to keep fit. If you are overweight or obese, exercising will help you lose weight and gain control over your heart failure.

The general goal of heart failure treatment is to treat the condition’s causes like coronary heart disease (CHD), high blood pressure or diabetes. Heart failure treatment includes lifestyle changes, medicines and ongoing care. While treating the cause of heart failure, you must do all that you can to maintain the current status of your heart so that it will not do permanent damage.

How to treat and help heart failure?

Maintaining a healthy lifestyle is just one of the several heart failure treatments. Talk with your doctor to decide the best route for you in concern to your heart failure treatment. Once diagnosed with heart failure, learn more about heart failure and its causes.

 

Source: www.nhlbi.nih.gov/health/health-topics/topics/hf/treatment.html

Get the Bare Facts on Heart Failure May 28, 2014

Generally speaking, heart failure occurs when the heart is incapable of pumping enough of the much needed, oxygen rich blood to the rest of your organs. Severe pain, temporary paralysis, damage to several different organs, and death may occur due to heart failure, but not every case is fatal. Some instances of heart failure result in moderate discomfort that passes, with the appropriate treatment, after a short while. As every person’s experience may vary, it is important to have a general understanding of heart failure and how it affects its victims.

  • Approximately 6 million people in the United States have suffered from some version of heart failure, be it mild or severe.
  • The densest collection of reported cases occurs within the Midwestern states, numbering 239 – 720 deaths per 10,000 citizens annually in each of 641 counties.
  • The average life expectancy of a patient that has been diagnosed with heart failure is five years, as has been the case in more than half of all documented victims.
  • One in nine deaths in 2009 occurred due, in some way, to heart failure.

 
While these numbers may seem alarming, the most important thing to take away is that heart failure presents a serious and continuous risk to the victim’s health. Making better life decisions or improving the quality of one’s life is the best way to start treating heart failure. For example, smoking, fatty foods, and a sedentary lifestyle should be avoided at all costs, as they create the perfect storm for the heart to fail.

The best opportunity one can have in the fight against heart disease is an early diagnosis. If you feel as if you may be at risk or suffer from shortness of breath, troubled breathing while lying down, swelling, or lethargy, consult a doctor immediately. Receiving the right medication and instruction before it’s too late can be the best possible weapons against an early death.

Possible Free Clinical Trial to Help You
At CardioKinetix, click here to learn more about our Parachute Trial Clinical Trial. The Parachute Device is a catheter based partitioning device deployed within the left ventricle for patients who have developed ischemic left sided heart failure following a heart attack.

CardioKinetix Announces Positive Clinical Data Showing Consistent Compelling Positive Results for Patients Treated with Minimally Invasive Structural Heart Device for Heart Failure May 22, 2014

Meta-Analysis Presented at EuroPCR Substantiate Potential of Breakthrough Treatment for Heart Failure Patients; Largest Group Studied to Date

Paris and Menlo Park, Calif. — CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced results of a meta-analysis study of the first-of-its-kind catheter-based Parachute® Ventricular Partitioning Device. Six-month clinical results from 91 U.S. and European patients with ischemic heart failure were presented at the 2013 EuroPCR Conference in Paris by Dr. Martyn Thomas, M.D., chairman of Cardiology at St. Thomas Hospital in London, England.

“The results of this meta-analysis, which represents the largest group of patients studied to date, are consistent with previous positive findings and continue to substantiate the Parachute treatment as a viable technology – a very exciting prospect for physicians treating patients with heart failure,” said Dr. Thomas. “The Parachute promises to revolutionize the treatment for heart attack survivors whose hearts enlarge over time and subsequently suffer from heart failure symptoms, offering hope for a better qualify of life for many patients.”

Clinical data from 91 patients to reach six-month follow up demonstrates successful delivery and deployment of the Parachute implant, without the occurrence of major adverse cardiac events (MACE) related to the device, in 90 percent (82/91) of patients at six months following treatment. In addition, six months following treatment, 89 percent of patients demonstrated improved or maintained New York Heart Association (NYHA) functional class status. Specifically in the NYHA III subgroup, 27 percent improved two classes. The treatment also demonstrated a reduction in left ventricular volume, with a 20 percent reduction in end diastolic volume and a 23 percent reduction in end systolic volume (p<0.001).

“The results of this meta-analysis along with the recent completion of our post-market safety surveillance trial add to our excitement about the Parachute treatment, which we believe holds the potential to improve the lives of tens of thousands of patients around the world and reduce the economic burden of heart failure,” said Maria Sainz, president and CEO of CardioKinetix. “Enthusiasm about the therapy continues to grow in the clinical community in Europe, where the therapy is available commercially, as well as in the United States, where the device is being studied in a landmark randomized pivotal trial.”

After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

About Heart Failure

Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]

About the Parachute® Ventricular Partitioning Device

The first-of-its-kind Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device first received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.

CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, JPMorgan Partners, Panorama Capital, H&Q Healthcare Investors, and H&Q Life Sciences Investors. For more information please visit www.cardiokinetix.com.

 

 

CardioKinetix contact:

Barry Templin

650-364-7016

barry@cardiokinetix.com

 

ACC 12 Month Data on 111 Patients May 13, 2014

ACC 12 Month Data on 111 PatientsACC 2014. Phil Adamson, Oklahoma Heart Hospital
Pooled Analysis of Percutaneous Ventricular Restoration (PVR) therapy using the Parachute Device in Patients with Ischemic Dilated Heart Failure

Know the Various Treatments for Heart Failure Available to You April 28, 2014

Have you or a loved one ever suffered from a case of sudden heart failure? If so, you understand how serious and devastating of an event it can be. Aside from the physical pain, going through heart failure can also lead to serious cases of depression, traumatic fear, and uncertainty. Fortunately, doctors and specialists understand the plight of heart failure victims and have dedicated countless hours of research toward finding a solution. Although there is no guaranteed solution, several methods and procedures have been developed that are proven to reduce the risk of dangerous cardiac episodes.

Medication

There’s a strong chance that your doctor has given you medicine for your heart failure, and taking it as prescribed is the best means of treatment currently available. There currently exist over ten different types of heart medication (Angiotensin converting enzyme inhibitors, Angiotensin II receptor blockers, Beta-blockers, etc.) and several varieties within each category. Depending on what your body’s specific symptoms are, you may need to take one or several of these medications.

Lifestyle Change

Changing one’s way of life can be extremely difficult, especially if the victim has lived their entire life without making much compromise. Unfortunately, the truth is that poor health decisions are a portion of the reason that heart failure occurs. Continuing to make unhealthy choices is tantamount to risking another episode due to a lack of willpower. Everyone has the power to change for the better, and doing so may be the first step in how to treat heart failure.

Surgery

While slightly more involved that simply taking medication, surgery has come a long way in preventing further severe cardiac episodes in patients that have already experienced one case of heart failure. The most common procedure is bypass surgery, which helps to route blood around a blocked heart artery. More intensive surgeries, such as heart transplants, do exist for the most extreme cases.

Possible Free Clinical Trial to Help You

At CardioKinetix, click here to learn more about our Parachute Trial Clinical Trial. The Parachute Device is a catheter based partitioning device deployed within the left ventricle for patients who have developed ischemic left sided heart failure following a heart attack.

CardioKinetix Releases One-Year Clinical Data Showing Consistent, Compelling Positive Results for Patients Treated with Minimally Invasive Structural Heart Device for Heart Failure April 7, 2014

Analysis from 111 Consecutive Patients Presented at ACC 2014 Substantiate Potential of Breakthrough Treatment for Heart Failure Patients

Menlo Park, Calif. – CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced results of a pooled analysis study of the first-of-its-kind catheter-based Parachute® Ventricular Partitioning Device. Twelve-month clinical results from 111 consecutive U.S. and European patients with ischemic heart failure were presented at the 2014 ACC Conference in Washington, D.C., by Philip Adamson, medical director at the Heart Failure Institute at Oklahoma Heart Hospital.

“The results of this pooled analysis, which represents the largest group of patients studied to date, continue to substantiate the Parachute treatment as a viable technology for patients with heart failure,” said Dr. Adamson. “As we analyze the longer time points in this population, we are beginning to observe the durable effects of the Parachute device.”

Parachute proves to be a straightforward technology with a very high procedural success rate of 96 percent (106/111). The twelve-month highlights from the data include:

  • Sustained reduction of left ventricle volumes (p < 0.0001) resulting in significant improvements in systolic function (ejection fraction, contractility index, and stroke work) and a significant reduction in left atrial volume reflected improved diastolic function
  • NYHA functional class improved or maintained in 86 percent of patients
  • Six-minute walk distance improved at follow-up (p < 0.05), with 47 percent of patients walking an additional 20 meters or more
  • Rates of death and the combined endpoint of death and repeat hospitalization for heart failure were 5.7 percent and 21.7 percent, respectively

“The results of this analysis add excitement about the Parachute treatment, which we believe holds the potential to improve the lives of tens of thousands of patients around the world and reduce the economic burden of heart failure,” said Maria Sainz, president and CEO of CardioKinetix. “As we amass more and more data with this technology, enthusiasm and confidence continue to build around the landmark U.S. randomized clinical trial, which is currently enrolling at 45 centers.”

After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

About Heart Failure

Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]

About the Parachute® Ventricular Partitioning Device

The novel Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device first received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.

CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Archer Ventures, Panorama Capital, H&Q Healthcare Investors (NYSE:HQH), and H&Q Life Sciences Investors (NYSE:HQL). For more information please visit www.cardiokinetix.com.

 

CardioKinetix contact:

Barry Templin

650-364-7016

btemplin@cardiokinetix.com

OH – The Christ Hospital Lindner Research Center December 11, 2013

Cincinnati, Ohio
Contact: Darlene Rock , 513-585-1766, Darlene.Rock@thechristhospital.com   
Principal Investigator: Eugene Chung, MD, FACC
Principal Investigator: Dean Kereiakes, MD, FACC

TCT 2013 Lansky December 11, 2013

TCT 12 Month Hemodynamic DataTCT 2013. Alexandra Lansky, Yale A.Lansky TCT 2013

CA – Cedars-Sinai Medical Center November 6, 2013

Los Angeles, California
Contact: Mane Arabyan 310-248-8515, mane.arabyan@cshs.org
Principal Investigator: Jon Kobashigawa, MD
Principal Investigator: Saibal Kar, MD
Principal Investigator: Michael Shehata, MD
Principal Investigator: Jeffrey Goodman, MD

MN – University of Minnesota Medical Center November 6, 2013

Minneapolis, Minnesota
Contact: Emily Caldwell 612-626-3656, caldw076@umn.edu
Principal Investigator: Gladwin Das, MD
Principal Investigator: Emil Missov, MD

NY – Mount Sinai Medical Center November 6, 2013

New York, New York
Contact: Hugo Bloise 212-241-8228, hugo.bloise-adames@mountsinai.org
Principal Investigator: George Dangas, MD
Principal Investigator: Sean Pinney, MD

PA – Pinnacle Health Cardiovascular Institute November 6, 2013

Wormleysburg, Pennsylvania
Contact: Gretchen Meise, RN 717-920-4400 x4280, gmeise@pinnaclehealth.org
Principal Investigator: Hemal Gada, MD
Principal Investigator: David Pawlush, MD

CardioKinetix Announces First Heart Failure Patients Treated in China with Novel Minimally Invasive Structural Heart Device October 14, 2013

Menlo Park, Calif. – CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced a new first with two patients successfully treated this week with the new catheter-based Parachute® Ventricular Partitioning Device in Beijing, China.

After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

“We are very proud that the first Parachute procedure in China was performed here in Beijing. China is currently experiencing a rapid increase in cardiovascular disease leading to a significant unmet need for better treatment options for patients with heart failure,” said Huo Yong, M.D., Director Heart Center and Department of Cardiology PKU-1st Hospital and President Chinese Society of Cardiology in Beijing, China.

“These initial cases in China mark another key milestone in CardioKinetix’s journey to bring Parachute to heart failure patients around the world,” said Maria Sainz, President and CEO of CardioKinetix Inc. “China represents a key strategic opportunity for the company as we further our international expansion.”

The introduction of the Parachute into the Chinese market will add significant experience to the program where the device already has CE Mark in Europe and is currently enrolling in the U.S. pivotal trial, PARACHUTE IV.

About Heart Failure
Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]

About the Parachute® Ventricular Partitioning Device
The novel Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device first received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, JPMorgan Partners, Panorama Capital, H&Q Healthcare Investors (NYSE:HQH), and H&Q Life Sciences Investors (NYSE:HQL). For more information please visit www.cardiokinetix.com.

CardioKinetix contact:
Barry Templin
650-364-7016
barry@cardiokinetix.com

VA – Virginia Commonwealth University Medical Center October 6, 2013

Richmond, Virginia
Contact: Melissa Sears, RN BSN 804-828-1601, mlsears@vcu.edu
Principal Investigator: Zachary Gertz, MD
Principal Investigator: Keyur Shah, MD

WA – Swedish Medical Center October 6, 2013

Seattle, Washington
Contact: Stephen Lubatti 206-215-6573, stephen.lubatti2@swedish.org
Principal Investigator: Oana Petrescu, MD
Principal Investigator: Paul Huang, MD

FL – Tallahassee Research Institute September 4, 2013

Tallahassee, Florida
Contact: Patty Knap, RN 850-431-5024, patty.knap@tmh.org
Principal Investigator: Wayne Batchelor, MD
Principal Investigator: Akash Ghai, MD

IA – Iowa Heart Center September 4, 2013

Des Moines, Iowa
Contact: Michelle Fopma 515-235-5114, mfopma@iowaheart.com
Principal Investigator: Mark Tannenbaum, MD
Principal Investigator: William Wickemeyer, MD

WI – Aurora St. Luke’s Medical Center September 4, 2013

Milwaukee, Wisconsin
Contact: Maggie Miller, RN 414-385-1853, maggie.miller@aurora.org
Principal Investigator: Suhail Allaqaband, MD
Principal Investigator: Nasir Sulemanjee, MD

CardioKinetix Announces First Heart Failure Patients Treated in Asia with Minimally Invasive Structural Heart Device August 29, 2013

Menlo Park, Calif. – CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced a new first with four patients successfully treated this week with the novel catheter-based Parachute® Ventricular Partitioning Device in Kuala Lumpur, Malaysia.

After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

“We are thrilled that the first Parachute procedure in Asia was performed here in Kuala Lumpur. There is a significant unmet need for better treatments for patients with heart failure in Malaysia, where heart disease is a growing public health concern,” said Robaayah Zambahari, M.D., Chief Executive Officer of Institut Jantung Negara (National Heart Institute) in Kuala Lumpur, Malaysia. “Heart failure symptoms have a significant negative impact on quality of life. Surgical treatments for the condition are invasive and typically performed in the later stages of the disease, and medical therapy does not address the underlying structural issues of ischemic heart failure. The Parachute device is an innovative new option that has demonstrated promising results in previous studies.”

“The expansion of the Parachute device into Asia is an important achievement for the company,” said Maria Sainz, President and CEO of CardioKinetix Inc. “Continuing to partner with leading clinicians and heart centers illustrates the promise the Parachute holds to bring a solution for the underserved heart failure patients around the world.”

The introduction of the Parachute into the Asian market will add significant experience to the program where the device already has CE Mark in Europe and is currently enrolling in the U.S. pivotal trial, PARACHUTE IV.

About Heart Failure
Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]

About the Parachute® Ventricular Partitioning Device
The novel Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device first received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, JPMorgan Partners, Panorama Capital, H&Q Healthcare Investors (NYSE:HQH), and H&Q Life Sciences Investors (NYSE:HQL). For more information please visit www.cardiokinetix.com.

CardioKinetix contact:
Barry Templin
650-364-7016
barry@cardiokinetix.com

EuroPCR 2013 6M Data June 30, 2013

EuroPCR 6 Month Data – Pooled AnalysisEuroPCR 2013. Martyn Thomas, St. Thomas Hospital, St. Thomas’ Hospital in London, England EuroPCR2013_Parachute6M_M Thomas_v8

CardioKinetix Announces Successful Parachute Live Case Transmission at 2013 EuroPCR Conference May 24, 2013

Paris and Menlo Park, Calif. – CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced the transmission of a live satellite feed of a clinical case using the first-of-its-kind catheter-based Parachute® Device at the annual 2013 EuroPCR Conference in Paris.

The Parachute procedure was performed by Dr. Martyn Thomas, M.D., chairman of Cardiology at St. Thomas’ Hospital in London, England, with assistance from Dr. Hüseyin Ince, Prof. of Medicine, University Hospital Rostock, Germany.

“Patients with ischemic heart failure have few effective options for their debilitating condition,” said Dr. Thomas. “I am always excited to perform the Parachute procedure, and give another patient hope for a better life. The procedure today went smoothly.”

“We are thrilled with the growing level of interest in the Parachute device demonstrated at EuroPCR this year,” said Maria Sainz, president and CEO of CardioKinetix. “Over and over again, we are hearing about the need for new therapies for MI survivors who develop heart failure over time. We believe that the Parachute addresses this unmet need with a technology that not only improves lives but could also reduce healthcare spending in the treatment of patients with heart failure.”

After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

About Heart Failure

Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]

About the Parachute® Ventricular Partitioning Device

The first-of-its-kind Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device first received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.

CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, JPMorgan Partners, Panorama Capital, H&Q Healthcare Investors, and H&Q Life Sciences Investors. For more information please visit www.cardiokinetix.com.

 

# # #

CardioKinetix contact:

Barry Templin

650-364-7016

barry@cardiokinetix.com

 

 



[i] Heart disease and stroke statistics – 2012 update: a report from the American Heart Association. Circulation 2012; 125: e2-e220.

IL – Prairie Education and Research Cooperative April 1, 2013

Springfield, Illinois
Contact: Lauren Bainter, 217-492-9100 ext 142, LBainter@prairieresearch.com
Principal Investigator: Jeff Goldstein, MD
Principal Investigator: Mark Stampehl, MD
Principal Investigator: Ziad Issa, MD

Principal Investigator: John Scherschel, MD

 

NY – Gates Vascular Instititute April 1, 2013

Buffalo, New York
Contact: Elizabeth Hejna 716-835-2966, ehejna@buffaloheartgroup.com
Principal Investigator: A.R. Zaki Masud, MD
Principal Investigator: Joseph Gelormini, MD

FL – Morton Plan Hospital – Heart and Vascular Institute of Florida March 30, 2013

Clearwater, Florida
Contact: Sue Fisher, 727-723-6511, SFisher@HAVI-North.com
Principal Investigator: Patrick Cambier, MD

PA – University of Pittsburg Medical Center – Presbyterian Hospital March 30, 2013

Pittsburgh, Pennsylvania
Contact: Laurie Dennis 412-647-6210, papugall@upmc.edu
Principal Investigator: Catalin Toma, MD
Principal Investigator: Marc Simon, MD

TX – Texas Heart Institute at St. Luke’s Episcopal Hospital March 30, 2013

Houston, Texas
Contact: James Chen, 832-355-9366, jchen@texasheart.org
Principal Investigator: Emerson Perin, MD
Principal Investigator: Andrew Civitello, MP

VA – Sentara Cardiovascular Research Institute March 30, 2013

Norfolk, Virginia
Contact: Tina Calayo, 757-388-1568, cawolszc@sentara.com
Principal Investigator: Allen Ciuffo, MD
Principal Investigator: John Herre, MD

LA – Cardiovascular Institute of the South January 16, 2013

Houma, Louisiana
Contact: Deanna K. Benoit, LPN, CCRC 985-873-5613, Deanna.Benoit@cardio.com
Principal Investigator: Peter Fail, MD
Principal Investigator: Richard Abben, MD

LA – LSU Health Sciences Center January 16, 2013

New Orleans, Louisiana
Contact: Cris Molina 504-568-2349, cmoli1@lsuhsc.edu
Principal Investigator: Frank Smart, MD
Principal Investigator: Murtuza J. Ali, MD

MI – St. Joseph Mercy-Michigan Heart January 16, 2013

Ann Arbor, Michigan
Contact: Kristy Wippler, RN, BSN, MHA 734-712-7602, kwippler@MichiganHeart.com
Principal Investigator: Marlo F. Leonen, MD
Principal Investigator: Arthur M. Szyniszewski, MD
Principal Investigator: Jihn Han, MD

TN – Tennova Healthcare – Turkey Creek Medical Center January 16, 2013

Knoxville, Tennessee
Contact: Linda Doughty, RN, BS, CCRC 865-218-7539, linda.doughty@hma.com
Principal Investigator: Malcolm T. Foster, MD
Principal Investigator: William Lindsay, MD

CardioKinetix Initiates Landmark Study of First-of-Its-Kind Treatment for Heart Failure in the United States January 8, 2013

Randomized Multicenter PARACHUTE IV Clinical Trial Will Compare Minimally Invasive Device to Optimal Medical Therapy

Menlo Park, Calif. — CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, announced the enrollment of the first patients in PARACHUTE IV, the randomized pivotal U.S. trial of the minimally invasive Parachute Ventricular Partitioning Device for the treatment of heart failure.

PARACHUTE IV is a multi-center pivotal trial designed to evaluate the PARACHUTE implant vs. optimal medical therapy (randomized 1:1) in approximately 500 patients with ischemic heart failure at up to 65 centers. The event-driven primary endpoint includes all-cause mortality and hospitalization for worsening heart failure. Other key endpoints include functional outcomes, quality of life, and hemodynamic measures by echocardiography.

The first implant with the Parachute device was performed by David Mego, M.D., assistant medical director at Arkansas Heart Hospital in Little Rock, Arkansas, who treated a 39-year-old female with NYHA class III heart failure referred by Carl Leding, M.D., director of the Congestive Heart Failure Clinic at Arkansas Heart Hospital.

Marco Costa, M.D., Ph.D., director of the Interventional Cardiovascular Center and the Research and Innovation Center at the Harrington Heart & Vascular Institute at Case Western Reserve University and co-principal investigator of the trial, said, “I am thrilled to be pioneering this exciting therapy in the United States, where there is a significant need for better treatments for this heart failure patient population.”

“Many patients who have had a heart attack experience an extremely poor quality of life due to the debilitating symptoms of heart failure, including shortness of breath, fatigue, lack of appetite, impaired thinking, and increased heart rate. A classic example is the patient just treated at Arkansas Heart Hospital, where the patient experienced a heart attack less than two years ago and now struggles with simple things like dressing, cooking, or playing outside with her son because of shortness of breath and extreme fatigue,” said William T. Abraham, M.D., the co-principal investigator of the trial and director of the Division of Cardiovascular Medicine and professor of internal medicine, physiology and cell biology at The Ohio State University Medical Center. “In October, three-year data on the initial patients treated with Parachute were presented at the TCT Conference by Dr. Marco Costa. These strong and encouraging results provide confidence to initiate a landmark randomized, pivotal trial where a positive outcome will establish this technology as a primary therapy option for the treatment of ischemic heart failure patients.”

The Parachute device offers the first minimally invasive catheter-based treatment to partition the coronary muscle damaged by a heart attack. The treatment excludes the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

“This initiation of the U.S. randomized pivotal study is a major milestone for CardioKinetix,” said Maria Sainz, president and CEO of CardioKinetix. “We are excited about the opportunity before us to make a major positive impact for patients with heart failure, and we believe that we have partnered with the right heart failure physicians and interventional cardiologists to enroll this trial quickly.”

About Heart Failure

Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]

About the Parachute™ Ventricular Partitioning Device

The first-of-its-kind Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.

CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute™ Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, JP Morgan Partners, and H&Q Healthcare Investors. For more information please visit www.cardiokinetix.com.

CardioKinetix contact:

Barry Templin
650-364-7016
barry@cardiokinetix.com


[i] Heart disease and stroke statistics – 2012 update: a report from the American Heart Association. Circulation 2012; 125: e2-e220.

AR – Arkansas Heart December 11, 2012

Little Rock, Arkansas
Contact: Teresa Dunegan, RN 501-748-8408, teresa.dunegan@arheart.com
Principal Investigator: Carl J. Leding, MD, FACC
Principal Investigator: David M. Mego, MD, FACC, FACP, FSCAI

TCT 6 Month Data – EU Confirmatory October 30, 2012

TCT 6 Month Data – EU ConfirmatoryTCT 2012. Martyn Thomas, St. Thomas Hospital, St. Thomas’ Hospital in London, England Parachute 6M TCT 2012

CardioKinetix Announces Successful Live Case Transmission at TCT 2012 Conference October 25, 2012

Menlo Park, Calif. and Miami, Fla. – CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced the transmission of a live satellite feed of a clinical case using the first-of-its-kind catheter-based Parachute™ Ventricular Partitioning Device to an audience of several hundred interventional cardiologists at the annual Transcatheter Cardiovascular Therapeutics (TCT) 2012 Conference in Miami, Fla.

The Parachute procedure was performed by Stefan Verheye, M.D., Ph.D., at the Antwerp Cardiovascular Institute, ZNA Middelheim Hospital, Belgium. The patient was enrolled as part of the PARACHUTE III clinical trial, which is designed to support development of post-market clinical data and allow European physicians to increase their experience with the technology.

“The Parachute procedure went very smoothly,” said Dr. Verheye. “We are excited to participate in the PARACHUTE III trial studying this important new treatment for patients with ischemic heart failure, a debilitating condition with limited effective treatment options.”

“We are very pleased with the level of interest and enthusiasm for the Parachute device and the data presented at TCT this year,” said Maria Sainz, president and CEO of CardioKinetix. “It’s clear that new therapies for patients with ischemic heart failure represent an important unmet clinical need and a very compelling opportunity to improve lives as well as reduce healthcare spending in the treatment of Heart Failure.”

Dr. Martyn Thomas, M.D., chairman of Cardiology at St. Thomas’ Hospital in London, England, presented six-month data from 32 patients treated in a European confirmatory trial. These data demonstrate a New York Heart Association (NYHA) class improvement of nearly half a class from a baseline of 2.5 to 2.1 (p < 0.01). The rate of hospitalization due to worsening heart failure was 12.5 percent at six months, with no incidence of stroke or death, confirming the results from the CE Mark approval data of the device in the U.S and Europe.

Dr. Marco Costa, M.D., Ph.D., professor of medicine, Case Western Reserve University in Cleveland, Ohio, presented three-year data from 31 patients treated in the two trials used for CE Mark approval. Results demonstrate a rate of hospitalization due to worsening heart failure of 29.7 percent at two years and 33.2 percent at three years for patients treated with the Parachute system, with the low rate of cardiac death of 6.5 percent at two years remaining unchanged at three years. These results suggest that percutaneous ventricle restoration with the Parachute system results in a plateau of the progression of heart failure in these patients. These outcomes compare very favorably with current medical therapy in a similar high-risk patient population.

Many heart attack survivors experience enlargement of the heart, causing a decrease in cardiac output that results in heart failure symptoms such as fatigue and shortness of breath. The healthy portion of the heart not affected by the heart attack has to compensate for the loss in output and becomes overloaded over time. Current treatment options for patients whose hearts have enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functioning, damaged heart muscle from the healthy, functional segment to decrease the overall volume of the left ventricle chamber and restore its optimal geometry and function.

About Heart Failure

Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]

About the Parachute™ Ventricular Partitioning Device

The first-of-its-kind Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.

CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute™ Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Panorama Capital, and H&Q Healthcare Investors. For more information please visit www.cardiokinetix.com.

 

# # #

CardioKinetix contact:
Barry Templin
650-364-701
barry@cardiokinetix.com



[i] Heart disease and stroke statistics – 2012 update: a report from the American Heart Association. Circulation 2012; 125: e2-e220.

CardioKinetix Announces Data from Latest European Study of Heart Failure Patients with First-of-Its-Kind Percutaneous Treatment October 24, 2012

Positive Six-Month and Three-Year Results Presented at TCT 2012 Demonstrate Meaningful and Sustained Improvement in Clinical Outcomes for Heart Failure Patients

Menlo Park, Calif.CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced clinical results showing meaningful and sustained low clinical events for patients with ischemic heart failure following Percutaneous Ventricular Restoration (PVR) therapy with the first-of-its-kind catheter-based Parachute™ Ventricular Partitioning Device.

Data was shown at two presentations today in Miami at the annual Transcatheter Cardiovascular Therapeutics (TCT) 2012 conference.

Dr. Martyn Thomas, M.D., chairman of Cardiology at St. Thomas’ Hospital in London, England, presented six-month data from 32 patients treated in a European confirmatory trial. These data demonstrate a New York Heart Association (NYHA) class improvement of nearly half a class from a baseline of 2.5 to 2.1 (p < 0.01). The rate of hospitalization due to worsening heart failure was 12.5 percent at six months, with no incidence of stroke or death, confirming the results from the feasibility trials.

Dr. Marco Costa, M.D., Ph.D., professor of medicine, Case Western Reserve University in Cleveland, Ohio, presented three-year data from 31 patients treated in feasibility trials from the U.S and Europe. Results demonstrate a rate of hospitalization due to worsening heart failure of 29.7 percent at two years and 33.2 percent at three years for patients treated with the Parachute system, with the low rate of cardiac death of 6.5 percent at two years remaining unchanged at three years. These results suggest that percutaneous ventricle restoration with the Parachute system results in a plateau of the progression of heart failure in these patients. These outcomes compare very favorably with current medical therapy in a similar high-risk patient population.

“With data now at three years, the long-term effect of the Parachute procedure remains highly promising for percutaneous treatment of heart failure patients. Particularly encouraging is the plateauing effect still maintained three years after treatment, which points to a potential slowing in the progression of heart failure,” said Dr. Thomas. “The durability of these results are demonstrated by the six-month results from the latest cohort of data, which are nearly the same as the feasibility results. Since the most recent cases were all done by operators without prior Parachute experience, the adoptability of this technology is very promising.”

“We continue to be very excited about the Parachute device and the promise it holds for addressing a significant unmet need for patients with debilitating ischemic heart failure,” said Maria Sainz, president and CEO of CardioKinetix. “In the next few months we look forward to initiating our U.S. pivotal trial, PARACHUTE IV, and beginning our European launch, two major milestones for our company.”

Many heart attack survivors experience enlargement of the heart, causing a decrease in cardiac output that results in heart failure symptoms such as fatigue and shortness of breath. The healthy portion of the heart not affected by the heart attack has to compensate for the loss in output and becomes overloaded over time. Current treatment options for patients whose hearts have enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functioning, damaged heart muscle from the healthy, functional segment to decrease the overall volume of the left ventricle chamber and restore its optimal geometry and function.

About Heart Failure

Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]

About the Parachute™ Ventricular Partitioning Device

The first-of-its-kind Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.

CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute™ Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Panorama Capital, and H&Q Healthcare Investors. For more information please visit www.cardiokinetix.com.

 

# # #

CardioKinetix contact:
Barry Templin
650-364-701
barry@cardiokinetix.com



[i] Heart disease and stroke statistics – 2012 update: a report from the American Heart Association. Circulation 2012; 125: e2-e220.

CardioKinetix Receives CE Mark Approval for Full Range of Sizes for First-of-Its-Kind Percutaneous Treatment for Heart Failure October 23, 2012

Menlo Park, Calif. CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced it has received CE Mark approval for the full size matrix of the company’s Parachute™ Ventricular Partitioning Device for Percutaneous Ventricular Restoration (PVR) therapy.

“The CE Mark approval for the full matrix of sizes of the Parachute implant is an important milestone; it will enable us to provide this innovative treatment to a wide range of heart failure patients in the European Union. We are finalizing our plans for our initial commercial launch in Europe in 2013,” said Maria Sainz, president and CEO of CardioKinetix.

“We have been very encouraged with the results of the Parachute cases at our hospital. Now that the Parachute is available in eight sizes, it addresses a significant unmet need in ischemic heart failure, with the potential to improve the lives of thousands patients with this devastating condition,” said Drs. Jozef Bartunek, Associate Director, and Marc Vanderheyden, Associate Director, from the Cardiovascular Center Aalst, OLV Ziekenhuis, Belgium

The Parachute device has been used in approximately 90 cases to date. Clinical results showing safety and meaningful and sustained low clinical events for patients with ischemic heart failure three years following treatment with the Parachute Ventricular Partitioning Device were presented at the 2012 European Society of Cardiology Conference in Munich in August. New data from patients treated with the Parachute device will be presented this week at the Transcatheter Cardiovascular Therapeutics (TCT) 2012 conference taking place October 22 – 26 in Miami, Fla.

Many heart attack survivors experience enlargement of the heart, causing a decrease in cardiac output that results in heart failure symptoms such as fatigue and shortness of breath. The healthy portion of the heart not affected by the heart attack has to compensate for the loss in output and becomes overloaded over time. Current treatment options for patients whose hearts have enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functioning, damaged heart muscle from the healthy, functional segment to decrease the overall volume of the left ventricle chamber and restore its optimal geometry and function.

About Heart Failure

Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]

About the Parachute™ Ventricular Partitioning Device

The first-of-its-kind Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.

CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute™ Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Panorama Capital, and H&Q Healthcare Investors. For more information please visit www.cardiokinetix.com.

 

# # #

CardioKinetix contact:
Barry Templin
650-364-701
barry@cardiokinetix.com


[i] Heart disease and stroke statistics – 2012 update: a report from the American Heart Association. Circulation 2012; 125: e2-e220.

CardioKinetix Chosen as One of FierceMedicalDevices’ “Fierce 15” Medical Device and Diagnostic Companies of 2012 October 2, 2012

Award Presented at AdvaMed 2012: The MedTech Conference

Menlo Park, Calif. – CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced that the company has been named to the FierceMedicalDevices “Fierce 15” list, designating it as one of the leading medical device and diagnostic companies of 2012.

FierceMedicalDevices editors chose this year’s winners based on their top management teams, notable financial backing, promising technologies and market opportunities. The awards were announced at an event that took place today during AdvaMed 2012: The MedTech Conference in Boston, Mass. CardioKinetix was chosen as one of the Fierce 15 based, in part, on its creativity and innovations in the industry.

“We’ll be paying detailed attention to CardioKinetix, particularly its pivotal study involving nearly 500 patients who will be testing its Parachute device to treat ischemic heart failure. The umbrella-like creation is inventive, delivered through a catheter and inserted into the femoral artery so it partitions off the heart’s damaged portion, restoring its function and shape in the process,” said FierceMedicalDevices Editor Mark Hollmer.

“We are very pleased to be included in the inaugural Fierce15 list of leading medical device and diagnostic companies,” said Maria Sainz, president and CEO of CardioKinetix. “Following our recent presentation of three-year data at the European Society of Cardiology conference, physicians globally have expressed enthusiasm about our innovative device, which has the potential to improve the lives of thousands patients with heart failure.”

Many heart attack survivors experience enlargement of the heart, causing a decrease in cardiac output that results in heart failure symptoms such as fatigue and shortness of breath. The healthy portion of the heart not affected by the heart attack has to compensate for the loss in output and becomes overloaded over time.
Current treatment options for patients whose hearts have enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functioning, damaged heart muscle from the healthy, functional segment to decrease the overall volume of the left ventricle chamber and restore its optimal geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About FierceMedicalDevices

An internationally recognized e-newsletter reaching more than 34,000 medical device and diagnostic industry professionals, FierceMedicalDevices provides subscribers with a quick authoritative briefing on the day’s top stories, with a special focus on clinical studies, FDA/EMEA regulations, and post-marketing. A complete list of “Fierce 15″ companies is available online at www.fiercemedicaldevices.com.

About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute™ Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Panorama Capital, and H&Q Healthcare Investors. For more information please visit www.cardiokinetix.com.

# # #

CardioKinetix contact:
Barry Templin
650-364-7016
barry@cardiokinetix.com

Left ventricular partitioning device in a patient with chronic heart failure: Short-term clinical follow-up September 6, 2012

Left ventricular partitioning device in a patient with chronic heart failure: Short-term clinical follow-up International Journal of Cardiology, 2012; I. Bozdag-Turan, B. Bermaoui, R.G. Turan, L. Paranskaya, G. D`Ancona, S. Kische, K. Hauenstein, C.A. Nienaber, H. Ince

Ince Case publication

ESC 3 Year Data August 29, 2012

ESC 3 Year DataESC 2012. Marco Costa, University Hospitals Case Medical Center, Case Western Reserve University ESC PARACHUTE Final2

CardioKinetix Announces Positive Three-Year Clinical Data for First-of-Its-Kind Minimally July 27, 2012

Results Presented at European Society of Cardiology Demonstrate Meaningful and Sustained Improvement in Clinical Outcomes for Heart Failure Patients

Munich, Germany and Menlo Park, Calif. – CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced clinical results showing meaningful and sustained low clinical events for patients with ischemic heart failure three years following Percutaneous Ventricular Restoration (PVR) therapy with the first-of-its-kind catheter-based Parachute™ Ventricular Partitioning Device.

Findings were presented today in Munich during the State of the Art – Novel Concepts in Heart Failure Treatments session at the 2012 European Society of Cardiology Conference by Marco Costa, M.D., Ph.D., director of the Interventional Cardiovascular Center and the Research and Innovation Center at the Harrington Heart & Vascular Institute, University Hospitals Case Medical Center, and professor of medicine, Case Western Reserve University in Cleveland, Ohio.

Data from thirty-one patients treated in the U.S and Europe with the Parachute system demonstrate that the New York Heart Association (NYHA) class improvement observed at one and two years was maintained at three years post treatment (average NYHA class of 2.6 at baseline vs. 1.8 at three years, p<0.0001). The rate of hospitalization due to worsening heart failure was 29.7 percent at two years and 33.2 percent at three years, and the low rate of cardiac death of 6.5 percent at two years remained unchanged at three years, suggesting that percutaneous ventricle restoration with the Parachute system results in a plateau of the progression of heart failure in these patients. These outcomes compare favorably with current medical therapy in a similar high-risk patient population.

“These results are compelling. The sustained improvements in functional capacity and plateauing effect seen in outcomes three years after treatment with the Parachute device are particularly encouraging, showing that we may be able to slow the progression of heart failure – a very exciting prospect,” said William T. Abraham, M.D., director of the Division of Cardiovascular Medicine and professor of internal medicine, physiology and cell biology at The Ohio State University Medical Center.

“We were already very excited about the two-year clinical data presented at the EuroPCR conference earlier this year. The unprecedented three-year results observed in this high-risk population treated with Parachute reinforces our initial enthusiasm and fuels our motivation to start the pivotal large randomized trial later this year,” said Dr. Costa. “In the two first-in-man studies, the Parachute device demonstrated its safety and sustained improvements in symptoms, heart function, and clinical outcomes over three years, pointing to a potential historical turning point in the treatment for post-MI heart failure patients.”

“This innovative device could address a significant unmet need in ischemic heart failure, with the potential to improve the lives of thousands patients with this debilitating condition,” said Maria Sainz, president and CEO of CardioKinetix. “We are focused on completing our real-world European post-market surveillance trial and initiating our U.S. pivotal trial to pursue our plans to bring this therapy to patients suffering from heart failure globally.”

Many heart attack survivors experience enlargement of the heart, causing a decrease in cardiac output that results in heart failure symptoms such as fatigue and shortness of breath. The healthy portion of the heart not affected by the heart attack has to compensate for the loss in output and becomes overloaded over time. Current treatment options for patients whose hearts have enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functioning, damaged heart muscle from the healthy, functional segment to decrease the overall volume of the left ventricle chamber and restore its optimal geometry and function.

About Heart Failure

Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]

About the Parachute™ Ventricular Partitioning Device

The first-of-its-kind Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.

CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute™ Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Panorama Capital, and H&Q Healthcare Investors. For more information please visit www.cardiokinetix.com.

 

# # #

CardioKinetix contact:

Barry Templin

650-364-7016

barry@cardiokinetix.com


[i] Heart disease and stroke statistics – 2012 update: a report from the American Heart Association. Circulation 2012; 125: e2-e220.

CardioKinetix Initiates European Post-Market Trial of First-of-Its-Kind Minimally Invasive Treatment for Heart Failure in Germany June 8, 2012

PARACHUTE III Clinical Trial Will Evaluate Benefits of Therapy in Real-World Setting

Menlo Park, Calif. – CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, announced today that it has begun enrollment in PARACHUTE III, a post-market safety surveillance trial, in Germany with the CE Marked Parachute™ Ventricular Partitioning Device.

After a heart attack, many heart failure patients experience enlargement of their left ventricle causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

The first implants with CE Marked Parachute devices were done in Heidelberg, Germany by Stefan Hardt, M.D., Department of Cardiology, Heidelberg University Clinic as part of the PARACHUTE III trial, which is designed to evaluate the long-term safety of the Parachute implant in a real-world setting in up to 100 patients with ischemic heart failure at up to 20 centers in Europe. Professor Hardt reported that all patients were treated successfully and discharged without procedure-related complications. A successful case was also performed by Heyder Omran, M.D., Ph.D., Department of Cardiology and internal Medicine, St. Marien-Hospital Abt. Innere Medizin in Bonn, Germany.

“The Parachute implant system represents an important advancement in treatment options for patients with ischemic heart failure,” said Dr. Martyn Thomas, M.D., chairman of Cardiology at St. Thomas Hospital in London, England, and the principle investigator for the PARACHUTE III study. “These first procedures in the PARACHUTE III trial represent the beginning of the largest clinical data evaluation for this new therapy to date. I am optimistic that the patients treated with the Parachute implant will experience positive results similar to those in prior trials of the device most recently reported during the 2012 EuroPCR meeting.”

CardioKinetix plans to continue expanding its post-marketing trial effort in Europe by adding hospitals in the UK, Spain, Italy, Belgium, Germany, and the Netherlands in coming months. The PARACHUTE III clinical trial will enable physicians in the European Union to increase their experience with the technology while continuing to develop the therapy.

About Heart Failure

Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.

About the Parachute™ Ventricular Partitioning Device

The first-of-its-kind Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.
Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About the PARACHUTE III Trial

PARACHUTE III is a dual-arm (Parachute vs. optimal medical therapy), open-label, multi-center trial designed to evaluate the Parachute implant in a real-world setting. The trial will enroll up to 100 patients with ischemic heart failure at up to 20 centers in Europe. The primary endpoint of the trial is procedural- and device-related Major Adverse Cardiac Events (MACE) through 60 months. Other key endpoints include hemodynamic measures by echocardiography (ECHO) and imaging measures by computed tomography (CT).

About CardioKinetix Inc.

CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute™ Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Panorama Capital, and H&Q Healthcare Investors. For more information please visit www.cardiokinetix.com.

CardioKinetix contact:
Barry Templin
650-364-7016
barry@cardiokinetix.com

Percutaneous Left Ventricular Partitioning in Patients with Chronic Heart Failure and a Prior Anterior Myocardial Infarction: Results of the PARACHUTE Trial June 1, 2012

Percutaneous Left Ventricular Partitioning in Patients with Chronic Heart Failure and a Prior Anterior Myocardial Infarction: Results of the PARACHUTE Trial
American Heart Journal, 2012; Vol. 163 Issue 5 pp. 812-820; Ernest L. Mazzaferri Jr., Sinisa Gradinac, Dragan Sagic, Petar Otasevic, Ayesha K. Hasan, Thomas L. Goff, Horst Sievert, Nina Wunderlich, Serjan D. Nikolic, William T. Abraham

AHJ 1yr PARACHUTE Cohort A + US FIM

CardioKinetix Announces Positive Two-Year Clinical Data for First-of-Its-Kind Minimally Invasive Treatment for Heart Failure May 18, 2012

Results Presented at EuroPCR Demonstrate Meaningful and Sustained Improvement in Clinical Outcomes, Suggesting Breakthrough Treatment for Heart Failure Patients

Paris and Menlo Park, Calif. — CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced two-year clinical results for the first-of-its-kind catheter-based Parachute™ Ventricular Partitioning Device, a Percutaneous Ventricular Restoration (PVR) therapy for patients with ischemic heart failure. Results were presented today during a Trials, Registries and Late Breaking Science Hot Line session at the 2012 EuroPCR Conference in Paris by Marco Costa, M.D., Ph.D., director of the Interventional Cardiovascular Center and the Research and Innovation Center at the Harrington Heart and Vascular Institute, University Hospitals Case Medical Center, Case Western Reserve University in Cleveland, Ohio.

Clinical data from the two first-in-human studies of the Parachute system presented today show meaningful and sustained low clinical events for patients with ischemic heart failure two years following treatment with the device.

Results from 31 treated U.S and European patients demonstrate a near-full New York Heart Association (NYHA) class improvement at two years compared to baseline (2.6 vs. 1.9, p<0.01). In addition, reduction in left ventricular volume was maintained out to two years (p<0.001). Furthermore, the procedure stabilized the remodeling process as demonstrated by no statistical change in post-procedure functional volume over a two-year period (p=0.74). The combined rate of all-cause death and hospitalization due to worsening heart failure was 16.1 percent at one year and 32.3 percent at two years. The rate of cardiac death was 6.5 percent at two years. These outcomes compare favorably with current medical therapy in a similar high-risk patient population.

“Heart failure is such a morbid condition and, in spite of our best efforts, we have so little to offer to our patients. Today we shared unprecedented news for cardiologists and heart failure patients. It is difficult to contain our enthusiasm because the procedure is relatively simple and the outcomes are surprisingly remarkable for such a high-risk population,” said Dr. Costa. “The sustained and concordant improvements in symptoms, heart function, and clinical outcomes are compelling, with a very acceptable safety profile. If these results are confirmed in the upcoming large randomized trial, the Parachute implant will revolutionize the treatment of patients with ischemic dilated cardiomyopathy, reducing debilitating symptoms and allowing patients with heart failure to live with dignity again.”

“We are extremely pleased with the two-year clinical results from the Parachute implant. This data supports the design of our randomized pivotal trial, in which we anticipate a potential reduction of death and hospitalization due to worsening heart failure on the order of 30 to 50 percent for patients treated with the Parachute system compared to optimal medical therapy,” said William T. Abraham, M.D., director of the Division of Cardiovascular Medicine and professor of internal medicine, physiology and cell biology at The Ohio State University Medical Center. “This innovative device has the potential to bring together two cardiology disciplines – heart failure and interventional cardiology – to address a significant unmet need in heart failure.”

“The presentation of this long-term clinical data is an exciting milestone for CardioKinetix,” said Maria Sainz, president and CEO of CardioKinetix. “We look forward to gathering additional evidence of the clinical benefits of the Parachute from our European trials as we prepare to start our pivotal trial of the device, which we believe holds the potential to improve the lives of tens of thousands of patients around the world.”

After a heart attack, many patients experience enlargement of the left ventricle of the heart, causing a decrease in cardiac output that results in heart failure symptoms such as fatigue and shortness of breath. The healthy portion of the heart not affected by the heart attack has to compensate for the loss in output and becomes overloaded over time. Current treatment options for patients whose heart has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

About Heart Failure

Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]

About the Parachute™ Ventricular Partitioning Device

The first-of-its-kind Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.

CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute™ Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Panorama Capital, and H&Q Healthcare Investors. For more information please visit www.cardiokinetix.com.

 

# # #

CardioKinetix contact:
Barry Templin
650-364-7016
barry@cardiokinetix.com

 


[i] Heart disease and stroke statistics – 2012 update: a report from the American Heart Association. Circulation 2012; 125: e2-e220.

EuroPCR 2 Year Data May 18, 2012

EuroPCR 2 Year DataEuroPCR 2012. Marco Costa, University Hospitals Case Medical Center, Case Western Reserve UniversityParachute EuroPCR 2012 final

PARACHUTE: Porto Case Study May 17, 2012

PARACHUTE: Porto Case StudyEuroPCR 2012. Guida Silva, Centro Hospitalar de Vila Nova de Gaiasilva case

 

PARACHUTE: Rostock Case Study May 17, 2012

PARACHUTE: Rostock Case StudyEuroPCR 2012. Huyesin Ince, Rostock Universityince case

EuroPCR Glimpse into the Future May 16, 2012

EuroPCR Glimpse into the FutureEuroPCR 2012. Huyesin Ince, Rostock University glimpse into the future

Maria Sainz Joins CardioKinetix as President and Chief Executive Officer May 7, 2012

Brings Proven Record of Success in Commercializing Innovative Therapies

Menlo Park, Calif. – CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, announced today that Maria Sainz has joined the company as president and chief executive officer. A veteran medical device executive, Maria brings more than 20 years of international experience to the role. Most recently Maria served as general manager of Stryker Neurovascular, which acquired Concentric Medical, Inc. in October 2011 under her leadership as president and CEO.

“We are delighted to welcome Maria to CardioKinetix,” said Casey Tansey, general partner at U.S. Venture Partners and the chairman of the company’s Board of Directors. “She is an exceptional leader with a proven record of success in bringing innovative new therapies to market internationally. I am confident that this strong commercial experience, as well as her commitment to improving quality of life for patients with cardiovascular disease, will serve CardioKinetix well as it moves toward its next stage of growth.”

“CardioKinetix is at an exciting time as we prepare for commercialization of the first-of-its-kind Parachute™ Ventricular Partitioning Device in Europe and begin the randomized pivotal trial of the therapy in the United States,” said Maria. “I feel fortunate to be part of bringing this innovative technology to heart failure patients around the world. There is a significant unmet need for new treatments for these patients, who suffer from debilitating symptoms and are in need of additional options for improving their quality of life.”

Prior to joining Concentric Medical, Ms. Sainz held several senior roles at Guidant Corporation including president of the Cardiac Surgery business; vice president, Global Marketing for Vascular Intervention; and vice president, Intermedics Cardiac Rhythm Management in Europe. Ms. Sainz received an M.A. in Languages from the University Complutense in Madrid, Spain and a Masters in International Management from the American Graduate School of International Management.

Maria will be based at the company’s headquarters in Menlo Park, Calif.

About the Parachute™ Ventricular Partitioning Device
The first-of-its-kind Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Delivered through a catheter inserted in the femoral artery, the small parachute-shaped implant partitions off the damaged portion of the heart, decreasing overall volume and restoring the geometry and function of the heart’s left ventricle. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the device.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute™ Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Panorama Capital, and H&Q Healthcare Investors. For more information please visit www.cardiokinetix.com.

# # #

CardioKinetix contact:
Barry Templin
650-364-7016
barry@cardiokinetix.com

CardioKinetix Wins Edison Award for the Parachute Ventricular Partitioning Device April 27, 2012

Awards Honor Innovation, Creativity and Ingenuity

Menlo Park, CA – CardioKinetix Inc., a pioneer in catheter-based treatments for heart failure, today announced that the first-of-its-kind Parachute™ Ventricular Partitioning Device has received an Edison Award in the Surgical Aid (Medical Device) category, one of the fifteen categories honored annually by the Edison Awards. The distinguished award symbolizes the persistence and excellence personified by Thomas Alva Edison, inspiring America’s drive to remain in the forefront on innovation, creativity and ingenuity in the global economy.

“It’s an honor to be recognized with such a prestigious award recognizing our innovative approach to treating heart failure patients,” said Serjan D. Nikolic, Parachute inventor, co-founder, and chief technology officer of CardioKinetix. “It has been very fulfilling to see the Parachute technology move from initial concept more than 10 years ago to availability today as a new treatment option to patients with heart failure.”

The ballot of nominees for the Edison Awards was judged by more than 3,000 senior business executives and academics from across the nation whose votes acknowledge the winner’s success in meeting the award criteria of Concept, Value, Delivery and Impact. The members of the Edison Awards Steering Committee are senior executives with diverse marketing, scientific, and business backgrounds who monitor the development and successful launch of innovative products each year.

“More than any year, this year’s winners demonstrate the enormous value of teamwork, experimentation, consumer focus and market awareness,” said Tom Stat, chairman of the Edison Awards’ Steering Committee. “It’s exciting to see companies like CardioKinetix continuing Thomas Edison’s legacy of challenging conventional thinking.”

The 2012 Edison Awards are sponsored by Nielson, Discovery Communications, Science Channel, USA Today, CSRware, and applepeak. For more information about the Edison Awards and a list of past winners, visit www.edison awards.com.

About Heart Failure
Approximately 23 million people in the world suffer mild to severe heart failure and 2.4 million new cases of heart failure are diagnosed each year. In the United States, heart failure is responsible for 11 million physician visits annually, and more hospitalizations than all forms of cancer combined.[i] Heart failure is one of the most resource-intensive conditions with direct and indirect costs in the United States estimated at $39.2 billion in 2010.[ii] Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. An estimated 20 to 30 percent of heart failure patients could benefit from percutaneous ventricular restoration therapy with the Parachute.

About the Parachute™ Ventricular Partitioning Device
The first-of-its-kind Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Delivered through a catheter inserted in the femoral artery, the small parachute-shaped implant partitions off the damaged portion of the heart, decreasing overall volume and restoring the geometry and function of the heart’s left ventricle. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is a pioneer in catheter-based treatments for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Panorama Capital, and H&Q Healthcare Investors. For more information please visit www.cardiokinetix.com.

# # #

CardioKinetix contact:

Barry Templin
650-364-7016
barry@cardiokinetix.com

 


[i] Emoryhealthcare.org

[ii] Lloyd-Jones D, Adams RJ, Brown TM, et al. Heart Disease and Stroke Statistics—2010 Update. A Report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee.* Circulation. 2010;121:e1-e170.

 

CardioKinetix Announces Late Breaking EuroPCR Session Featuring First-of-Its-Kind Minimally Invasive Treatment for Heart Failure April 7, 2012

Two-Year Data on Breakthrough Treatment to be Presented on Friday, May 18

Menlo Park, Calif. — CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced that clinical trial data from the first-of-its-kind Parachute™ Ventricular Partitioning Device for the treatment of patients with ischemic heart failure will be presented at the 2012 EuroPCR Conference in Paris.

Two-year results from two first-in-human studies of the Parachute system will be presented during a Trials, Registries and Late Breaking Science Hot Line session by Marco Costa, M.D., Ph.D., director of the Interventional Cardiovascular Center and the Research and Innovation Center at the Harrington Heart and Vascular Institute, University Hospitals Case Medical Center, Case Western Reserve University in Cleveland, Ohio.

The session, titled “Percutaneous ventricular restoration therapy in patients with ischemic dilated heart failure: 2-year clinical and echocardiographic outcomes of the first-in-human study of the parachute left ventricle partitioning device” will take place on Friday, May 18 at 9:13 a.m. CET in Room 251.

At 2:10 p.m. CET on Wednesday, May 16, Hüseyin Ince, M.D., Ph.D., professor of Medicine at the University Hospital Rostock in Rostock, Germany, will provide an overview of the Parachute device and Rostock experience during a session titled “Emerging Interventional Technologies for Heart Failure Management” in Room 351.

In addition, two Parachute patient cases will be presented at EuroPCR on Thursday, May 17 in Room 242A:

  • At 9:00 a.m. CET, Guida Silva, M.D., from the Centro Hospitalar de Vila Nova de Gaia in Porto, Portugal will present “Percutaneous ventricular partitioning: a specific solution for a specific problem.”
  • At 9:14 a.m. CET, Dr. Ince will present “Volume reduction therapy for heart failure with a new transcatheter device.”

After a heart attack, many patients experience enlargement of the left ventricle of the heart, causing a decrease in cardiac output that results in heart failure symptoms such as fatigue and shortness of breath. The healthy portion of the heart not affected by the heart attack has to compensate for the loss in output and becomes overloaded over time. Current treatment options for patients whose heart has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

About Heart Failure
Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]

About the Parachute™ Ventricular Partitioning DeviceThe first-of-its-kind Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute™ Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Panorama Capital, and H&Q Healthcare Investors. For more information please visit www.cardiokinetix.com.

# # #

CardioKinetix contact:

Barry Templin
650-364-7016
barry@cardiokinetix.com

 


[i] Heart disease and stroke statistics – 2012 update: a report from the American Heart Association. Circulation 2012; 125: e2-e220.

CardioKinetix Demonstrates Positive Results in German Sub-Study using the Parachute™ for Percutaneous Ventricular Restoration Therapy in the Treatment of Ischemic Heart Failure March 8, 2012

Menlo Park, CA — CardioKinetix Inc., a medical device company that has developed a novel transcatheter implant called the ParachuteTM Ventricular Partitioning Device (ParachuteTM), announced today that a German sub-study from the PARACHUTE Cohort B trial continued to show positive results after heart failure patients were treated with the ParachuteTM. The results were presented today by Dr. Hüseyin Ince, Prof. of Medicine, University Hospital Rostock, Germany, during the 27th annual Interventional Cardiology conference in Snowmass Village, CO.

When implanted in the left ventricle, the ParachuteTM implant partitions damaged muscle, isolating the non-functional muscle segment from the functional segment, which decreases the overall volume and restores a more normal geometry and function in the left ventricle. The sub-study presented data on eight of the 80 patients to be enrolled in Cohort B of the ongoing PARACHUTE trial. The average patient studied was 62 years of age, had an NYHA class of 2.8, and an ejection fraction (EF) of 28% at baseline.

At three months meaningful improvements were shown in the following critical measurements:

–One full New York Heart Association (NYHA) class improvement (2.8 at baseline vs. 1.6 at 3 months, p < 0.05)
–18% ejection fraction (EF) improvement (28% at baseline vs. 33% at 3 months, p < 0.05)
–62% 6 Minute Walk improvement (305 meters vs. 495 meters, p < 0.05)
–14% reduction in Left Ventricular End-Diastolic Volume (LVEDV) and Left Ventricular End-Systolic Volume (LVESV) reduction (LVEDV: 220 ml at baseline vs. 190 ml at 3 months, p < 0.05; LVESV: 154 ml vs. 132 ml, p < 0.05)
–17% reduction in ProBNP, a diagnostic marker evaluating the severity of heart failure (850 pg/ml at baseline vs. 702 pg/ml at 3 months, p < 0.05)

“After the implant of the ParachuteTM, my heart failure patients showed significant improvement in their symptom scores and quality of life,” said Dr. Hüseyin Ince, “Early studies suggest that by reducing volume and restoring a more normal geometry and function to the left ventricle we can arrest the progression of heart failure, reduce mortality and improve quality of life.”

“We continue to be encouraged by the early clinical results demonstrated by the ParachuteTM implant. In all of our previous studies we have seen similar improvements in treated heart failure patients,” said Thomas Engels, Vice President of Clinical Affairs of CardioKinetix, Inc., “We look forward to collecting additional data on the ParachuteTM as we begin our early commercialization efforts in Europe and start our pivotal trial in the United States.”

About the ParachuteTM Ventricular Partitioning Device
The ParachuteTM is a catheter based partitioning device deployed within the left ventricle for patients who have developed ischemic heart failure following a heart attack. The ParachuteTM implant partitions the damaged muscle, isolating the non-functional muscle segment from the functional segment, which decreases the overall volume and restores a more normal geometry and function in the left ventricle.

The ParachuteTM implant is comprised of a fluoropolymer (ePTFE) membrane stretched over a nitinol frame. The device is deployed into the apex of the left ventricle and partitions off the portion of the ventricle affected by the damaged myocardium in order to treat patients with ischemic heart failure.

About the PARACHUTE Trial
PARACHUTE is a dual-arm (ParachuteTM vs. Optimal Medical Therapy), open-label, multi-center registry designed to evaluate the ParachuteTM implant in ischemic heart failure patients in 14 centers across Europe. The PARACHUTE trial enrolled 19 patients in Cohort A and will enroll up to 80 patients in Cohort B. The primary endpoint of the trial is device related Major Adverse Cardiac Events (MACE) at 6 months. Other key endpoints include: hemodynamic measures by echocardiography (ECHO) and imaging measures by computed tomography (CT).

About CardioKinetix Inc.
CardioKinetix (www.cardiokinetix.com) has developed a novel transcatheter implant called the ParachuteTM Ventricular Partitioning Device (ParachuteTM). The ParachuteTM intends to treat heart failure resulting from a heart attack in patients worldwide by improving overall cardiac function.

CardioKinetix contact:
Barry Templin
650-364-7016
barry@cardiokinetix.com

Kerckhoff-Klinik February 29, 2012

Dr. Liebetrau
Bad Nauheim, Germany

Percutaneous Ventricular Restoration in a Chronic Heart Failure Patient February 23, 2012

Percutaneous Ventricular Restoration in a Chronic Heart Failure PatientEuroInterv.2006;2:128-131; M. Skowasch; G. Robertson; N. Wunderlich, S. Nikolic, A. Khairkhahan, H. Sievert.

First-in-Man Implantation of Left Ventricular Partitioning Device February 23, 2012

First-in-Man Implantation of Left Ventricular Partitioning Device in a Patient With Chronic Heart Failure: Twelve-Month Follow-up;Journal of Cardiac Failure, 2007;Vol.13 No.6:517-520; P. Otasevic, MD, D. Sagic, MD, PhD, Z. Antonic, MD, S. Nikolic, PhD, A. Khairakhan, MSC, B. Radovancevic, MD, Sinisa Gradinac, MD, PhD.

Percutaneous Implantation of an Intraventricular Device February 23, 2012

Percutaneous Implantation of an Intraventricular Device for the Treatment of Heart Failure: Experimental Results and Proof of ConceptJournal of Cardiac Failure, 2009;Vol.15 No.9:790-797; S. Nikolic, PhD, FACC, A. Khairkhahan, MS, M. Ryu, DVM, G. Champsaur, MD, FACC, E. Breznock, PhD, DVM, M.Dae, MD.

Percutaneous Implantation of the Left Ventricular February 23, 2012

Percutaneous Implantation of the Left Ventricular Partitioning Device for Chronic Heart Failure: A Pilot Study with 1-Year Follow-UpEuropean Journal of Heart Failure, 2010; Vol.12 No.6:600-606; Sagic D, Otasevic P, Sievert H, Elsasser A, Mitrovic V, Gradinac S.

Rostock University Clinic February 21, 2012

Prof. Christoph Nienaber ; Prof. Hüseyin Ince
Rostock, Germany

St. Thomas Hospital February 21, 2012

Dr. Martyn Thomas
London, United Kingdom

Left Ventricular Apex Occluder; Description of a Ventricular Partitioning Device February 18, 2012

Left Ventricular Apex Occluder; Description of a Ventricular Partitioning DeviceEuroInterv.2006;2:125-0127; H. Sharkey, S. Nikolic, PhD, A. Khairkhahan, M. Dae, MD.

PARACHUTE: Percutaneous Treatment of Ischemic Heart Failure February 18, 2012

PARACHUTE: Percutaneous Treatment of Ischemic Heart FailureTCT 2011. Serjan Nikolic, CTO, CardioKinetix, Inc.

OH – The Ohio State University February 18, 2012

Columbus, Ohio
Contact: Shawna Oxier 614-247-6797, shawna.oxier@osumc.edu
Principal Investigator: Ernest L. Mazaferri, Jr., MD
Principal Investigator: Garrie Haas, MD

OH – University Hospitals Case Western February 18, 2012

Cleveland, Ohio
Contact: Nadine Norton 216-844-2636, nadine.norton@uhhospitals.org
Principal Investigator: Guilherme Oliveira, MD
Principal Investigator: Daniel Simon, MD, FACC, FAHA, FSCAI

Cardiovascular Center Frankfurt February 18, 2012

Prof. Horst Sievert
Frankfurt, Germany

Heidelberg University Clinic February 18, 2012

Prof. Stefan Hardt
Heidelberg, Germany

CardioKinetix Receives Expanded CE Mark Approval for World’s First Percutaneous Left Ventricular Partitioning Device, the Parachute™, for Treatment of Ischemic Heart Failure January 30, 2012

Menlo Park, CA – CardioKinetix Inc., a medical device company that has developed a novel transcatheter implant called the Parachute™ Ventricular Partitioning Device (Parachute™), announced today that it has received CE Mark approval for two additional sizes of the Parachute™ implant.

After a heart attack, many heart failure patients experience enlargement of their left ventricle causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged are limited. The Parachute™ implant partitions the damaged muscle, isolating the non-functional muscle segment from the functional segment, which decreases the overall volume and restores a more normal geometry and function in the left ventricle. In clinical studies to date, the Parachute™ implant has shown to stop the progression of heart failure, reduce mortality, and improve quality of life.

“We are pleased to have received additional CE Mark approvals for the Parachute™ implant, and are enthusiastic about introducing the Parachute™ to treat heart failure patients in the European Union,” said Wes Johnson, President and CEO of CardioKinetix Inc. “These approvals will support our early commercialization efforts in select European markets through our PARACHUTE III clinical trial”.

CE Mark approval for the Parachute™ in Europe was supported by data from both the PARACHUTE clinical trial and PARACHUTE US feasibility trial. To support the development of post market clinical data, the Company is initiating the PARACHUTE III clinical trial. This trial will enable physicians in the European Union to increase their experience with the technology while continuing to develop the therapy.

About the Parachute™ Ventricular Partitioning Device

The Parachute™ is a catheter based partitioning device deployed within the left ventricle for patients who have developed ischemic heart failure following a heart attack. The Parachute™ implant partitions the damaged muscle, isolating the non-functional muscle segment from the functional segment, which decreases the overall volume and restores a more normal geometry and function in the left ventricle.

The Parachute™ implant is comprised of a synthetic fluoropolymer (ePTFE) membrane stretched over a nitinol frame. The device is deployed into the apex of the left ventricle and partitions off the portion of the ventricle affected by the damaged myocardium in order to treat patients with ischemic heart failure.

About the PARACHUTE Trial

PARACHUTE is a dual-arm (Parachute™ vs. Optimal Medical Therapy), open-label, multi-center registry designed to evaluate the Parachute™ implant in ischemic heart failure patients in 14 centers across Europe. The PARACHUTE trial enrolled 19 patients in Cohort A and will enroll up to 80 patients in Cohort B. The primary endpoint of the trial is device related Major Adverse Cardiac Events (MACE) at 6 months. Other key endpoints include: hemodynamic measures by echocardiography (ECHO) and imaging measures by computed tomography (CT).

About the PARACHUTE III Trial

PARACHUTE III is a dual-arm (Parachute™ vs. Optical Medical Therapy), open-label, multi-center registry, using CE Marked product, designed to evaluate the Parachute™ implant. The trial will enroll up to 100 patients with ischemic heart failure in up to 20 centers in Europe. The primary endpoint of the trial is procedural and device related Major Adverse Cardiac Events (MACE) through 60 months. Other key endpoints include: hemodynamic measures by echocardiography (ECHO) and imaging measures by computed tomography (CT).

About CardioKinetix Inc.

CardioKinetix (www.cardiokinetix.com) has developed a novel transcatheter implant called the Parachute™ Ventricular Partitioning Device (Parachute™). The Parachute™ intends to treat heart failure resulting from a heart attack in patients worldwide by improving overall cardiac function.

CardioKinetix contact:

Barry Templin
650-364-7016
barry@cardiokinetix.com

First Patients in Portugal, Latvia, Slovenia, and the United Kingdom Treated with CardioKinetix’s Parachute Ventricular Partitioning Device January 5, 2012

Menlo Park, CA – CardioKinetix Inc., a medical device company that has developed a novel transcatheter implant called the Parachute™ Ventricular Partitioning Device (Parachute™), announced today that the first patients in Portugal, Latvia, Slovenia and the United Kingdom have been treated with the Parachute™ implant as part of the PARACHUTE clinical trial. Up to 80 patients are currently being enrolled in the second cohort of the PARACHUTE trial in 14 centers across Europe and the Company expects that enrollment will be completed in 2012.

After a heart attack, many heart failure patients experience enlargement of their left ventricle causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged are limited. The Parachute™ implant partitions the damaged muscle, isolating the non-functional muscle segment from the functional segment, which decreases the overall volume and restores a more normal geometry and function in the left ventricle. In clinical studies to date, the Parachute™ has been shown to stop the progression of heart failure, reduce mortality, and improve quality of life.

“The expansion of the PARACHUTE trial into these four new markets, in addition to the Parachute™ implants already completed in Germany and Serbia, will broaden physicians’ exposure to the Parachute™ implant in the European Union,” said Wes Johnson, President and CEO of CardioKinetix Inc. “Enrollments in other key European countries are expected in the coming months. We are pleased with the interest shown in the trial to date and encouraged by the current pace of enrollment”.

About the Parachute™ Ventricular Partitioning Device

The Parachute™ is a catheter based partitioning device deployed within the left ventricle for patients who have developed ischemic heart failure following a heart attack. The Parachute™ implant partitions the damaged muscle, isolating the non-functional muscle segment from the functional segment, which decreases the overall volume and restores a more normal geometry and function in the left ventricle.

The Parachute™ implant is comprised of a fluoropolymer (ePTFE) membrane stretched over a nitinol frame. The device is deployed into the apex of the left ventricle and partitions off the portion of the ventricle affected by the damaged myocardium in order to treat patients with ischemic heart failure.

About the PARACHUTE Trial

PARACHUTE is a dual-arm (Parachute vs. Optimal Medical Therapy), open-label, multi-center registry designed to evaluate the Parachute™ implant in ischemic heart failure patients in 14 centers across Europe. The PARACHUTE trial enrolled 19 patients in Cohort A and will enroll up to 80 patients in Cohort B. The primary endpoint of the trial is device related Major Adverse Cardiac Events (MACE) at 6 months. Other key endpoints include: hemodynamic measures by echocardiography (ECHO) and imaging measures by computed tomography (CT).

About CardioKinetix Inc.

CardioKinetix (www.cardiokinetix.com) has developed a novel transcatheter implant called the Parachute™ Ventricular Partitioning Device (Parachute™). The Parachute™ intends to treat heart failure resulting from a heart attack in patients worldwide by improving overall cardiac function.

CardioKinetix contact:

Barry Templin
650-364-7016
barry@cardiokinetix.com

CardioKinetix Inc. Raises $44 Million in Series E Financing September 20, 2011

MENLO PARK, CA – CardioKinetix Inc., a medical device company that has developed a novel transcatheter implant called the PARACHUTE™ Ventricular Partitioning Device (PARACHUTE™), announced today that it has raised $44 million in a two-tranche Series E financing. The financing was led by new investors SV Life Sciences and New Leaf Venture Partners, who joined existing investors, including U.S. Venture Partners, J.P. Morgan Partners, H&Q Healthcare Investors (NYSE: HQH) and H&Q Life Sciences Investors (NYSE: HQL).

Parachute™, which recently received the CE Mark, is implanted into the left ventricle of the heart in a simple catheter lab procedure and is intended to treat patients with heart failure resulting from a myocardial infarction or heart attack. The Company is currently conducting clinical studies in Europe and the FDA has approved an IDE Pivotal Trial for Parachute™ based on the results from a feasibility study. The Company hopes to continue to demonstrate safety in its clinical studies as well as improve symptoms and function and reduce hospitalization for the millions of patients suffering from heart failure.

In conjunction with the financing, Paul LaViolette, Partner at SV Life Sciences, and Jeani Delagardelle, Managing Director at New Leaf Venture Partners will join CardioKinetix’s Board of Directors.

“This financing provides CardioKinetix the capital necessary to substantially progress the development of our PARACHUTE™ device, including conducting clinical studies to further support the initial commercialization of Parachute™ in Europe and a PMA submission to FDA,” said Wes Johnson, President and CEO of CardioKinetix Inc. “Further, the addition of Paul and Jeani to our Board will supplement the extensive operational and financial expertise available to our management team.”

“We are excited about teaming up with CardioKinetix to help advance an innovative and promising cardiology-friendly treatment for ischemic heart failure patients with limited options,” said Paul LaViolette of SV Life Sciences.

About CardioKinetix Inc.

CardioKinetix (www.cardiokinetix.com) has developed a novel transcatheter implant called the PARACHUTE™ Ventricular Partitioning Device (PARACHUTE™). The PARACHUTE™ intends to treat heart failure resulting from a heart attack or myocardial infarction in patients worldwide by improving overall cardiac function.

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