CLEVELAND — University Hospitals (UH) Case Medical Center and CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced promising results for the first-of-its-kind catheter-based Parachute™ Ventricular Partitioning Device, a Percutaneous Ventricular Restoration Therapy (PVRT) technology for patients with ischemic heart failure.
The two-year clinical results were presented today (May 18, 2012, 9 a.m.) during a Trials, Registries and Late Breaking Science Hot Line session at the 2012 EuroPCR Conference in Paris by UH Case Medical Center's Marco Costa, MD, Director of the Interventional Cardiovascular Center and the Research and Innovation Center at UH Case Medical Center's Harrington Heart & Vascular Institute and Professor, Case Western Reserve University School of Medicine.
Clinical data from the two first-in-human studies of the Parachute system presented today show meaningful and sustained low clinical events two years following treatment with the device.
"Heart failure is such a morbid condition, and in spite of our best efforts, we have so little to offer to our patients," said Dr. Costa, who was the national principal investigator for the initial trial. "Today we shared unprecedented news for cardiologists and heart failure patients. This novel technology could revolutionize care for our patients because the procedure is relatively simple and the outcomes are surprisingly remarkable for such a high-risk population."
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-value<0.01). In addition, reduction in left ventricular volume was maintained out to two years (p-value<0.001). Furthermore, the procedure stabilized the remodeling process as demonstrated by no statistical change in post-procedure functional volume over a two-year period (p-value=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.
"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, MD, director of the Division of Cardiovascular Medicine and professor of internal medicine, physiology and cell biology at The Ohio State University Medical Center who was also part of the first U.S. trial. "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."
"The presentation of this long-term clinical data is an exciting milestone for CardioKinetix," said Maria Sainz, president and CEO of CardioKinetix. "We look forward to gathering additional evidence in our European trials of the clinical benefits of the Parachute and as we prepare to start our pivotal trial with the device, which we believe holds the potential to improve the lives of tens of thousands of patients around the world."
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 overtime. Current treatment options for patients whose heart has enlarged are limited.
Through a small catheter inserted in the femoral artery (large thigh 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 next phase of the trial will be to enroll close to 500 patients in both the United States and Europe. UH Case Medical Center and The Ohio State University Medical Center will serve as the focal points for the efforts conducted nationally.
"The sustained and concordant improvements in symptoms, heart function and clinical outcomes are compelling, with a very acceptable safety profile," Dr. Costa said. "If these results are confirmed in the upcoming large randomized trial, the Parachute implant will transform the treatment of patients with ischemic dilated cardiomyopathy, reducing debilitating symptoms and dramatically improving the quality of life for our patients."