Pioneering Medical Innovations

Category: Claret Medical

FDA Panel Reviews Claret Medical’s Sentinel Cerebral Protection System for TAVR

February 27, 2017—Claret Medical Inc. announced that in an open public hearing of the US Food and Drug Administration’s Circulatory System Devices Panel held on February 23, virtually all panel members recommended the de novo application of the company’s Sentinel cerebral protection system (CPS) be granted, which would enable commercialization of the device in the United States. A formal vote was not taken, as the Sentinel CPS is a medium-risk accessory device reviewed as a de novo application, advised the company.

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FDA Panel Says Yes to Sentinel Approval

Despite the cloud of questions surrounding its clinical efficacy, an FDA advisory panel overwhelmingly recommended approval for the Sentinel Cerebral Protection System. As a de novo application for a lower-risk device, the Sentinel did not require a formal panel vote.

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