Claret Medical has received CE Mark approval in Europe for its next generation Sentinel Cerebral Protection System (CPS), which is designed to prevent emboli from reaching the brain during transcatheter aortic valve replacement (TAVR) procedures. While competing products simply deflect debris to reduce the risk of stroke, the Sentinel is the only device to filter the blood stream to actually remove dangerous debris headed towards the brain.
The catheter-based device is inserted through the right radial artery and has two filters which are placed at the junction of the brachiocephalic and right common carotid arteries to capture and prevent any debris from moving toward the brain. The Sentinel was also designed to improve both device ergonomics and vessel wall apposition when compared with previous generation products. Claret hopes to expand the device indication to include use during different valve replacement and other cardiac procedures shortly. The Sentinel is currently undergoing a multicenter clinical trial to gain FDA approval in the near future.