CardioKinetix has reported positive three-year clinical data of its minimally invasive Parachute ventricular partitioning device, following Percutaneous Ventricular Restoration therapy in heart failure patients.
The Parachute device, through a small catheter, is implanted into 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.
The trial, which has enrolled 31 patients across US and Europe, is designed to demonstrate the safety and efficacy of Parachute device in treating patients with heart failure, caused by damage to the heart muscle following a heart attack.
The results demonstrated meaningful and sustained low clinical events in heart failure patients as well as the New York Heart Association (NYHA) class improvements were observed at one and two years and was maintained at three years post treatment (average NYHA class of 2.6 at baseline vs. 1.8 at three years, p<0.0001).
Harrington Heart & Vascular Institute Interventional Cardiovascular Center and the Research and Innovation Center director Dr.Marco Costa said, "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."
CardioKinetix president and CEO Maria Sainz said, "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."