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Medical Devices / Submissions and Approvals

Claret Medical Gains FDA Clearance for Its Sentinel Cerebral Protection System

June 6, 2017

Claret Medical has received de novo clearance from the FDA for the Sentinel cerebral protection system (CPS).

The device captures and removes debris dislodged during transcatheter aortic valve replacement before it reaches the brain.

The Sentinel is positioned away from the aortic arch, which minimizes interference with the valve replacement catheters.

 In the clinical trial, use of Sentinel reduced strokes by 63 percent in the first 72 hours after TAVR and maintained a substantial difference at 90 days. — Cynthia Jessup

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