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.