Claret Medical said today that the FDA granted de novo clearance for its Sentinel device, which is designed to trap blood clots before they reach the brain during heart valve replacement procedures.
The Sentinel uses a pair of filters, 1 in the brachiocephalic artery another in the left common carotid artery, to trap debris released during transcatheter aortic valve replacement that could cause a cerebral embolism. Although the device met its primary safety endpoint in a pivotal study (major adverse cardiac and cerebrovascular events at 30 days), it missed the primary efficacy endpoint of reduction in median new lesion volume in protected territories. In February an FDA advisory panel recommended approval for Sentinel, despite the efficacy question.
Today Santa Rosa, Calif.-based Claret said it plans to “immediately” launch the device in “select” high-volume TAVR centers. Sentinel has an ICD code for reimbursement and the company said it’s working with the Centers for Medicare & Medicaid Services on winning a new technology add-on payment.
“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.,” president & CEO Azin Parhizgar said in prepared remarks. “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.”
“Strokes are devastating – they are random and unpredictable, and they are 1 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,” added Sentinel trial clinical steering chairman Dr. Martin Leon of Columbia University Medical Center/New York-Presbyterian Hospital. “The 63% reduction in clinical strokes in the first 72 hours after TAVR, combined with the fact that 1 in 4 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.”
Claret filed for FDA clearance in September 2016 for Sentinel, which won CE Mark approval in the European Union in 2013.
