The European Union (EU) has granted CE mark approval to CardioKinetix for the full size matrix of its percutaneous ventricular restoration device, designed to treat patients with ischemic heart failure caused by damage to the heart muscle following a heart attack
Using a small catheter inserted in the femoral artery, the Parachute ventricular partitioning device is deployed into the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy segment, and to decrease the overall volume of the left ventricle and restore its geometry and function.
The minimally invasive implant, which is performed in the catheterisation laboratory under conscious sedation, showed sustained low clinical events in patients with heart failure, and improved overall cardiac function and quality of life.
Cardiovascular Centre Aalst associate directors Dr Marc Vanderheyden and Dr Jozef Bartunek in a joint statement said that the centre 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 said.
CardioKinetix president and CEO Maria Sainz said the CE mark approval for the full matrix of sizes will enable the company to provide new treatment to various heart failure patients in the EU.
"We are finalising our plans for our initial commercial launch in Europe in 2013," Sainz said.
In the US, the Parachute implant is an investigational device limited by federal law, and is not available for sale.