CardioKinetix has reported two-year clinical data from the first-in-human studies of the Parachute Ventricular Partitioning device.
The data showed meaningful and sustained low clinical events for patients with ischemic heart failure following treatment with the device.
The study reported that patients treated with the Parachute system demonstrated a near-full New York Heart Association (NYHA) class improvement at two years compared to baseline.
In addition, reduction in left ventricular volume was maintained in the heart failure patients as well as no statistical change in post-procedure functional volume over a two-year period was observed.
The Ohio State University Medical Center internal medicine, physiology and cell biology professor and Cardiovascular Medicine director William Abraham said, "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."
The Parachute device is a catheter based percutaneous ventricular restoration (PVR) therapy that partitions the damaged muscle, isolates the non-functional muscle segment from the functional segment, and reduces the overall volume and restores normal geometry and function in the left ventricle.