FDA Update: Agency Approves TAVR Valves For Asymptomatic Severe AS
The U.S. Food and Drug Administration (FDA) has approved the Sapien 3, Sapien 3 Ultra and Sapien 3 Ultra Resilia TAVR valves from Edwards Lifesciences to treat patients with asymptomatic severe aortic stenosis (AS).
This decision comes following results from the EARLY TAVR trial, presented at TCT 2024 and published in The New England Journal of Medicine, which found that patients with asymptomatic severe AS who underwent TAVR with the Sapien 3 valve had a reduced risk of unplanned hospitalization, all-cause mortality and stroke compared to those monitored with clinical surveillance.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Structural Heart Disease
Keywords: United States Food and Drug Administration, Aortic Valve Stenosis, ACC Advocacy, Transcatheter Aortic Valve Replacement
