The first-of-its-kind catheter-based Parachute(TM) Ventricular Partitioning Device for patients with ischemic heart failure. Clinical data from two first-in-human studies of the Parachute system show meaningful and sustained low clinical events for patients with ischemic heart failure two years following treatment with the device.
May 22, 2012 — CardioKinetix Inc. 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 during a late-breaking trial session at EuroPCR 2012 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 last week 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 a 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.
“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,” said Costa.
“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.”
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.
For more information: www.cardiokinetix.com