US FDA Advisory Panel Backs Claret’s Sentinel TAVR Filter
Executive Summary
The panelists said the agency should approve the filter, which is used to protect the brain during transcatheter aortic heart-valve replacement surgery, despite ongoing questions about its effectiveness.
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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.