The FDA has cleared the use of Claret Medical’s Sentinel cerebral protection system in the U.S., making the device the first and only of its kind on the market that reduces the risk of stroke by capturing and removing debris that can break free during transcatheter aortic valve replacement (TAVR) and cause a stroke, the company said.
The regulatory agency cleared the device under de novo classification, which allows for a speedier approval process for low- to moderate-risk devices. The company said it expects to make Sentinel available in certain high-volume TAVR centers immediately and is working to make the device eligible for CMS reimbursement.
Data from the pivotal Sentinel trial showed the device reduced strokes by 63% in the first 72 hours after TAVR and maintained a substantial difference at 90 days. Additional studies indicated the device removed visible debris headed towards the brain in 99% of TAVR cases, regardless of the type of replacement valve used and with no added risk.
“We believe that Sentinel will create a paradigm shift in how TAVR patients are treated in the U.S.,” Azin Parhizgar, Claret Medical’s president and CEO, said in a statement. “The science behind the device has set a high bar for other embolic protection devices to meet and its safety record is indisputable.”
The Sentinel system was evaluated in more than 1,000 patients in multiple studies, including three randomized controlled trials, making it one of the most studied TAVR devices, the company said. To date, more than 3,500 patients globally have been protected with the device, and Sentinel is the only cerebral protection system commercially available in Europe, selected Asian countries and the U.S.
Other big players in the TAVR field are Boston Scientific, Medtronic and Edwards Lifesciences..