Sentinel Cerebral Protection System filed with FDA for yse during TAVR - Claret Medical

Claret Medical has announced its filing of a marketing application with the FDA for clearance of the Sentinel Cerebral Protection System (CPS). The Sentinel CPS is the only 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. There are currently no cerebral embolic protection technologies available in the US to protect TAVR patients from cerebral embolic events.

The filing includes data from the recently completed SENTINEL pivotal IDE trial, a prospective, randomized, controlled, blinded study of 363 TAVR patients at 19 centers in the US and Germany. Trial endpoints included reduction in new ischemic cerebral infarcts, major adverse cardiac or cerebrovascular events, neurocognitive outcomes, and qualitative and quantitative histopathological findings. The SENTINEL trial allowed inclusion of all commercially available TAVR platforms available in the US.

Results from the recently published CLEAN-TAVI blinded, randomized, controlled trial in the Journal of the American Medical Association (JAMA) and the MISTRAL-C randomized, controlled trial, published in Eurointervention, showed that patients protected with the system had significantly fewer and smaller new ischemic cerebral infarcts following the procedure than unprotected patients. MISTRAL-C also demonstrated that the TAVR procedure created embolic debris in 100 percent of patients, which could have traveled to the brain if not for the protection offered by the Sentinel CPS.