First TAVR Filter Gets US FDA Panel Date
Executive Summary
Claret Medical’s Sentinel CPS missed its primary endpoint during a pivotal trial but showed greater benefits for patients receiving Sapien XT valves, and affirmed that it trapped debris and had a clinical benefit.
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Claret Medical’s Sentinel embolic protection device for transcatheter aortic valve replacement is set to go before US FDA’s Circulatory System Devices Panel on Feb. 23. Trials found the de novo device is safe, but the agency has some concerns that a primary efficacy endpoint was missed.
TCT 2016: Missed Endpoint Does Not Blur Claret's Focus On 2017 US Clearance For SENTINEL
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