US EditionFDA Approves SAPIEN 3 Platform for Asymptomatic Severe Aortic Stenosis
- On May 5, 2025, the FDA approved Edwards Lifesciences' SAPIEN 3 platform for asymptomatic severe aortic stenosis patients in the U.S.
- This approval follows the EARLY TAVR trial, which compared outcomes of asymptomatic patients assigned to TAVR or watchful waiting over 3.8 years.
- The trial showed 26.8% of TAVR patients faced death, stroke, or hospitalization versus 45.3% in clinical surveillance, indicating better outcomes with early intervention.
- Philippe Genereux of Morristown Medical Center emphasized that current recommendations for managing aortic stenosis patients, which advise delaying intervention until symptoms appear, should be revised to incorporate earlier use of TAVR.
- This approval represents a groundbreaking expansion of TAVR use to include patients with severe aortic stenosis who do not yet show symptoms, signaling a potential move away from the traditional approach of delaying treatment until symptoms appear.
52 Articles
52 Articles
FDA approves SAPIEN 3 platform for asymptomatic severe aortic stenosis
The U.S. Food and Drug Administration has approved Edwards Lifesciences' SAPIEN 3 platform, a transcatheter aortic valve replacement (TAVR) therapy, for patients with severe aortic stenosis without symptoms. The approval is the first for TAVR in asymptomatic patients.
FDA Approves SAPIEN 3 Platform for Asymptomatic Severe Aortic Stenosis
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 aortic stenosis without symptoms. The approval is the first for…
Interventional cardiologists of the General Hospital (HG) of Saltillo, Coahuila, belonging to the Institute of Security and Social Services of State Workers (ISSSTE), successfully performed the procedure of Implante Valvular Aortico Transcateter (TAVI) to two patients of 73 and 89 years of age. According to the director of the HG Saltillo, Roberto Valdés Charles, this procedure is characterized by being minimally invasive and is used to treat pa…
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