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The FDA expanded the indication for transcatheter aortic valve replacement (TAVR) with CoreValve's Evolute line of prostheses to include patients at intermediate surgical risk, Medtronic .
The approval for patients with 3% or greater 30-day mortality risk from open-heart surgery to replace the aortic valve was based on results from the SURTAVI trial, which showed similar 24-month risk of death and disabling stroke with CoreValve and surgery in this population.
The expanded approval included the original CoreValve, Evolut R, and Evolut PRO systems and adds to their previous indication for treatment of symptomatic severe aortic stenosis in high and greater surgical risk patients.
Sapien XT and Sapien 3 TAVR devices had approval expanded to the intermediate surgical risk population in August 2016, based on the PARTNER 2 trial.