FDA Clears Claret Medical's Sentinel Cerebral Protection System for TAVR Procedures

June 5, 2017 – Claret Medical, Inc. announced that it has received clearance from the US Food and Drug Administration (FDA) for the Sentinel cerebral protection system (CPS), via de novo classification, enabling commercialization of the device in the United States. The Sentinel device offers embolic protection against the risk of stroke during transcatheter aortic valve replacement (TAVR).

The Sentinel CPS, which received European CE Mark approval in 2013, is commercially available in Europe, selected Asian countries, and now, the United States.

Claret Medical will immediately launch the device in selected high-volume TAVR centers of excellence across the United States. The company is also collaborating with the Centers for Medicare and Medicaid Services to develop a pathway to achieve a new technology add-on payment and has already established an International Classification of Diseases diagnostic code for reimbursement of the Sentinel.

According to the company, use of Sentinel reduced strokes by 63% in the first 72 hours after TAVR and maintained a substantial difference at 90 days in the pivotal SENTINEL randomized controlled trial.

In November, Claret Medical announced the findings from the SENTINEL trial at TCT 2016, the 28th annual Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC. The study results were published by Samir R. Kapadia, MD, et al in Journal of the American College of Cardiology (2017;69:367–377).

In the company's announcement of FDA clearance, the SENTINEL Trial Clinical Steering Committee Chairman, Martin Leon, MD, commented, “Strokes are devastating—they are random and unpredictable, and they are one of the biggest fears of any TAVR patient and their treating physician. Anything we can do as clinicians to reduce the risk of brain injury is extremely meaningful. The 63% reduction in clinical strokes in the first 72 hours after TAVR, combined with the fact that one in four patients had an average of 25 particles of debris collected that were visible to the naked eye, is striking. The device was delivered safely, added minimal time to the procedure, and performed as intended with capture of embolic material and reduction in ischemic brain injury.”

Dr. Leon continued, “As TAVR physicians, in this new era of transcatheter cerebral embolic protection, we now have an obligation to communicate this information during a shared decision-making process to patients and their families as they are informed about TAVR treatment options.”