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