First TAVR Filter Gets US FDA Panel Date

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.

A device that is intended to cut the risk of embolism during transcatheter aortic valve replacement (TAVR) procedures – but showed uneven results in recent clinical trial data – will be up for discussion during the first US FDA device advisory panel meeting announced for 2017.

The Circulatory System Devices Panel plans to meet Feb. 23 in Gaithersburg, Md., to discuss the de novo application for Claret Medical Inc.’s Sentinel cerebral protection system, a

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