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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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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.

TCT 2016: Missed Endpoint Does Not Blur Claret's Focus On 2017 US Clearance For SENTINEL

Results of the SENTINEL trial, announced at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium conference, show that the Sentinel transcatheter embolic protection device is safe and captures embolic debris in 99% of transcatheter aortic valve replacement patients. Sentinel may also lower the 30-day stroke rate and new brain-lesion volume compared to unprotected TAVR, but the reduction failed to be statistically significant in the trial.

‘Core Pillars’ Of Safety And Innovation Take Center Stage In FDA Reports

The US FDA has issued a pair of reports focused on device safety and innovation. The reports describe recent steps the agency has taken to improve in the two areas, and what it plans to do next.

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