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The U.S. Food and Drug Administration has approved Edwards Lifesciences' SAPIEN 3 platform, a transcatheter aortic valve ...
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 ...
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.
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 ...
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 ...
"There is an urgent need to change practice and TAVR guidelines for the treatment of aortic stenosis patients, which currently recommend ‘watchful waiting’ until symptoms develop," said ...
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