FDA approves Sentinel Cerebral Protection System to protect against risk of stroke during TAVR procedures.- Claret Medical

Claret Medical announced that it has received regulatory clearance from the FDA for the Sentinel Cerebral Protection System (CPS), via de novo classification, enabling U.S. commercialization of the device. The Sentinel is the first and only device available in the U.S. that offers protection against the risk of stroke by capturing and removing debris dislodged during transcatheter aortic valve replacement (TAVR) before it reaches the brain.

In the pivotal SENTINEL randomized controlled trial, use of Sentinel reduced strokes by 63 percent in the first 72 hours after TAVR and maintained a substantial difference at 90 days. Claret Medical will launch the device in selected high volume TAVR centers of excellence across the U.S., beginning immediately.The company is also collaborating with the Centers for Medicare and Medicaid Services (CMS) to develop a pathway to achieve a new technology add on payment and has already established an ICD code for reimbursement of the Sentinel.

TAVR is an effective and popular method to replace a diseased aortic heart valve in a minimally invasive way, but recent studies have found that almost one in 10 patients experience a clinically-apparent stroke due to the procedure. The majority of strokes occur during the procedure or within 72 hours, likely caused by debris that breaks loose from the native heart valve or aortic wall and travels towards the brain, leading to potential neurological damage.

Comment:The device has been commercially available in Europe since 2013 but is the first to be cleared in the US for stroke prevention during TAVR and is being launched in selected high-volume TAVR centers of excellence.