CardioKinetix has received CE mark approval for the full size matrix of its Parachute Ventricular Partitioning Device for percutaneous ventricular restoration (PVR) therapy.
The Parachute device offers a minimally invasive catheter-based treatment option to partition the damaged muscle, after a heart attack, excluding the non-functioning heart muscle from the healthy, functional segment to decrease the overall volume of the left ventricle chamber and restore its optimal geometry and function.
According to a company release, the Parachute device has been used in approximately 90 cases to date. Clinical results showing safety and meaningful and sustained low clinical events for patients with ischaemic heart failure three years following treatment with the Parachute Ventricular Partitioning Device were presented at the 2012 European Society of Cardiology Conference in Munich in August. New data from patients treated with the Parachute device is being presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2012 conference.
“We have been very encouraged with the results of the Parachute cases at our hospital. Now that the Parachute is available in eight sizes, it addresses a significant unmet need in ischaemic heart failure, with the potential to improve the lives of thousands patients with this devastating condition,” said Jozef Bartunek, associate director, and Marc Vanderheyden, associate director, from the Cardiovascular Center Aalst, OLV Ziekenhuis, Belgium.
“The CE mark approval for the full matrix of sizes of the Parachute implant is an important milestone; it will enable us to provide this innovative treatment to a wide range of heart failure patients in the European Union. We are finalising our plans for our initial commercial launch in Europe in 2013,” said Maria Sainz, president and CEO of CardioKinetix.
The Parachute Ventricular Partitioning Device received CE mark in 2011. In the USA, the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.