Claret Medical has obtained clearance from the FDA through its de novo classification pathway for the Sentinel Cerebral Protection System, a cerebral protection device designed to capture embolic debris during transcatheter aortic-valve replacement using a proximal and distal filter. The company said it is working with the CMS to get a new technology add-on payment for the device.
Claret Medical's TAVR embolic protection system wins FDA clearance
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