Positive results from CardioKinetix’s Parachute device clinical trial on ischemic heart failure

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.