CardioKinetix Discusses Chinese Trial of Parachute Heart Failure Device
CardioKinetix has announced significant results from a three-month Chinese clinical trial of its Parachute Ventricular Partitioning Device, designed to treat left-side heart failure.
The device is the first minimally invasive catheter-based treatment that partitions an enlarged left ventricle, separating nonfunctioning heart segments from healthy ones and restoring the muscle’s normal shape and function, the devicemaker said.
Highlights of the three-month trial include a 97 percent procedural success rate, increase in heart function as seen in the primary endpoint and hemodynamic section data, and quality-of-life metrics indicating patients feel better and have better overall functioning, the Menlo Park, Calif., company said Monday.
The Parachute China trial is the fourth to demonstrate significant clinical program results, said CardioKinetix President and CEO Maria Sainz, noting that more than 50 patients across nine hospitals in China have been treated with the device.
The Parachute heart-assist device received the CE mark in 2011. Distribution in the U.S. is limited to investigational use only. — Jason Scott