California-based medical device company CardioKinetix landed CE Mark approval in the European Union for the full suite of its Parachute ventricular partitioning devices, including 8 sizes of the device designed to provide support to weakened heart muscles. .
"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," president & CEO Maria Sainz said in prepared remarks. "We are finalizing our plans for our initial commercial launch in Europe in 2013."
More than 20 million people around the world are affected by heart failure, including approximately 6 million in the U.S., according to the press release. The Parachute device has been implanted in about 90 patients so far, the company reported.
The Parachute implant is inserted into the heart via a catheter threaded through the femoral artery. Once inside, the device springs open and attaches to the walls of the heart to provide support for patients whose left ventricle was left enlarged after a heart attack.
Clinical results for the Parachute showed 3-year safety and sustained low clinical events on ischemic heart failure patients, according to data originally presented in August at the 2012 European Society of Cardiology Conference in Munich. CardioKinetix plans to unveil more data during this weeks’ Transcatheter Cardiovascular Therapeutics meeting in Miami, Fla.
CardioKinetix last November raised $44 million for its Parachute ventricular partitioning device after the device received the CE Mark approval. The system is used for clinical investigation and not yet available for sale in the U.S.
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