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