First TAVR Filter To Reach FDA Panel Will Get Questions On Missed Endpoint

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.

A missed trial endpoint could lead to challenging questions at a Feb. 23 US FDA advisory panel meeting for Claret Medical Inc.'s Sentinel embolic protection device for transcatheter aortic valve replacement procedures. Market-watchers expect FDA to ultimately approve the device, but how physicians adopt the technology remains to be seen.

Questions released ahead of the Feb. 23 Circulatory System Devices Panel meeting suggest FDA is looking for assurance that a...