News

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 ...
MedPage Today on MSN6d
FDA Approves Sapien 3 TAVR for Asymptomatic Aortic Stenosis
FDA approved the Sapien 3 transcatheter aortic valve replacement (TAVR) platform for treatment of severe aortic stenosis ...
TCTMD6d
FDA Approves TAVI for Asymptomatic Patients With Severe Aortic Stenosis
The agency’s decision for the balloon-expandable Sapien 3 platform is based on groundbreaking results from EARLY TAVR.
Early transcatheter aortic valve replacement reduces cardiovascular events in asymptomatic aortic stenosis patients
New analysis from the EARLY TAVR trial showed patients between the age of 65 and 70 years old derived the most benefits of a ...
Healio6d
FDA approves first TAVR platform to treat severe asymptomatic aortic stenosis
Edwards Lifesciences announced the FDA approved its transcatheter aortic valve replacement platform for treatment of severe ...
U.S. News & World Report2d
FDA Approves SAPIEN 3 Platform for Asymptomatic Severe Aortic Stenosis
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 ...
MassDevice6d
Edwards wins FDA nod for TAVR in aortic stenosis without symptoms
Edwards Lifesciences (NYSE: EW) received FDA approval for its Sapien 3 TAVR for severe aortic stenosis (AS) without symptoms.
The Daily Gazette3d
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 ...