Claret Medical® has gained regulatory clearance from the U.S. FDA for the Sentinel™ Cerebral Protection System (CPS), via de novo classification, enabling U.S. commercialization of the device.
We’ve followed the Sentinel story for a while now, most recently last November when Claret Medical was touting solid IDE study results. 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.
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. It is already the most-studied device in the field of TAVR cerebral protection, having been systematically evaluated in more than 1,000 patients in multiple studies, including three randomized controlled trials. More than 3,500 patients worldwide have been protected with the device to-date, and it is the only cerebral protection system commercially available in Europe, selected Asian countries, and now, the U.S.
The Sentinel is simple to use, with 99 percent deployment success in a median deployment time of four minutes.2 It is securely positioned away from the aortic arch, avoiding damage to that anatomy, minimizing interference with TAVR catheters, and enabling physicians to focus solely on the TAVR procedure.
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.
“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,” stated Martin Leon, MD, of Columbia University Medical Center/New York-Presbyterian Hospital, and chairman of the SENTINEL Trial Clinical Steering Committee. “The 63 percent 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.”
“The advent of ‘protected TAVR’ is here, and we believe that Sentinel will create a paradigm shift in how TAVR patients are treated in the U.S.,” said Claret Medical President and Chief Executive Officer Azin Parhizgar, PhD. “The science behind the device has set a high bar for other embolic protection devices to meet and its safety record is indisputable. By helping to reduce the occurrence of peri-procedural strokes, we intend to provide patients and physicians with greater peace of mind as they approach a TAVR procedure.”
Source: Claret Medical, Inc.