SANTA ROSA, CA — The US Food and Drug Administration (FDA) today cleared the first cerebral protection device for use in patients undergoing transcatheter aortic-valve replacement (TAVR), according to the device manufacturer[1].
Sentinel Cerebral Protection System
The Sentinel Cerebral Protection System (Claret Medical) contains a proximal and distal filter to capture embolic debris dislodged by the procedure.
Earlier this year, an FDA advisory panel took no formal vote but gave the device a green light after agreeing it carries a low safety risk and that it can't be good for embolic debris to reach the brain.
But cardiologists and neurologists on that advisory panel struggled in interpreting data from the pivotal SENTINEL trial reported at TCT 2016, which failed to show the device significantly reduced the primary end point of new brain lesion volume on MRI.
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.
Claret is "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 ICD code for reimbursement of the Sentinel," the company news release stated.
Claret is discussing options around a postmarket registry to track clinical outcomes in new patients treated with the Sentinel, as was suggested by FDA advisory panel members, but nothing is currently in place, and the FDA did not mandate a postmarket study, a company spokesperson told heartwire from Medscape.
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Heartwire from Medscape © 2017
Cite this: FDA Clears Sentinel for Cerebral Protection During TAVR - Medscape - Jun 05, 2017.
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