MENLO PARK, Calif.--(BUSINESS WIRE)-- 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 its 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.1
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.
1 Heart disease and stroke statistics – 2012 update: a report from the American Heart Association. Circulation 2012; 125: e2-e220.
Barry Templin, 650-364-7016