Claret Medical Submits Marketing Application to FDA for Combination Device
Claret Medical has filled a marketing application with the FDA for clearance of the Sentinel Cerebral Protection System (CPS).
The Sentinel CPS is a device designed to protect the brain by capturing and removing debris dislodged during transcatheter aortic valve replacement (TAVR) that enters cerebral circulation and carries the potential for stroke.
Data from its pivotal IDE trial encompassed 363 TAVR patients at 19 centers in the U.S. and Germany. The Sentinel trial allowed addition of all commercially available TAVR platforms available in the U.S.
The Sentinel CPS received the CE Mark in 2013. — Cynthia Jessup