Claret Medical‘s Sentinel cerebral protection system won CE Mark approval for use providing protection against embolism during transcatheter aortic valve replacement.The Sentinel uses a filter-based system to remove potentially dangerous embolic debris that may be dislodged during a TAVI procedure, preventing the debris from traveling to the brain. Claret plans immediately to put the device on the market, according to a press release.
“Interventional cardiologists told us they would value a dual filter system that was easier to use with a more ergonomically-designed delivery system for faster device delivery and even more precise placement. The Sentinel CPS was developed in response to this request,” president and CEO Dr. Azin Parhizgar said in prepared remarks.
Santa Rosa, Calif.-based Claret last month asked the FDA for its blessing in conducting clinical trials for the device in the U.S. The company is working towards trials at 15 sites in Europe and the U.S., in an effort to gain FDA clearance.
