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Early transcatheter aortic valve replacement (TAVR) in asymptomatic severe aortic stenosis reduces the risk of death, stroke, and heart failure hospitalization compared to clinical surveillance.
FDA Approves SAPIEN 3 Platform for Asymptomatic Severe Aortic Stenosis By Lori Solomon HealthDay ReporterMONDAY, May 5, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved ...
A transcatheter aortic valve replacement platform was approved for severe asymptomatic aortic stenosis. Edwards Lifesciences’ TAVR platform is the first to be approved in this population.
Asymptomatic patients with severe aortic stenosis can now undergo transcatheter aortic valve replacement, thanks to the US Food and Drug Administration’s approval of the new indication for the balloon ...
In the EARLY TAVR trial, which informed the approval, patients with asymptomatic severe aortic stenosis were randomly assigned to either TAVR or watchful waiting. During a median follow-up of 3.8 ...
platform for the treatment of patients with asymptomatic severe aortic stenosis (AS), expanding its use to a broader population. Marking a first approval for a TAVR system’s use in asymptomatic ...
MONDAY, May 5, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved the SAPIEN 3 platform, a transcatheter aortic valve replacement (TAVR) therapy, for patients with severe ...