CardioKinetix has obtained CE mark approval for its full size matrix of its percutaneous ventricular restoration device to treat patients with ischemic heart failure.
The Parachute ventricular partitioning device uses a small catheter for insertion in the femoral artery and is deployed into the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy functional segment.
Clinical studies conducted on Parachute device showed sustained low clinical events in patients with heart failure and improved overall cardiac function and quality of life.
Cardiovascular Center Aalst associate directors Marc Vanderheyden and Dr. Jozef Bartunek in a joint statement said that the center is encouraged with the results of the Parachute cases at its hospital.
"Now that the Parachute is available in eight sizes, it addresses a significant unmet need in ischemic heart failure, with the potential to improve the lives of thousands patients with this devastating condition," Vanderheyden and Bartunek added.
CardioKinetix president and CEO Maria Sainz said the CE mark approval for the full matrix of sizes of the Parachute implant will enable the company to provide new treatment to various heart failure patients in the EU.
"We are finalizing our plans for our initial commercial launch in Europe in 2013," Sainz added.