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 (
|Contact: Mike Ferrari|
University Hospitals Case Medical Center