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 ...
TCTMD10d
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.
MedTech Dive6d
Edwards gains expanded TAVR label for asymptomatic patients
The medical technology company expects the new indication to increase sales in its transcatheter aortic valve replacement ...
Healio10d
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 ...
Medical Device Network on MSN10d
FDA approves Edwards’ TAVR system for asymptomatic aortic stenosis patients
Edwards’ SAPIEN 3 platform becomes the first TAVR system approved by the FDA for asymptomatic severe aortic stenosis patients ...
Orange County Business Journal10d
FDA Approves New Indication for Edwards’ TAVR Platform
The FDA approved Edwards Lifesciences Corp.'s Sapien 3 platform for patients with asymptomatic severe aortic stenosis.
KTBS7d
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 ...
MedPage Today11d
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 early in the disease process while patients still had no symptoms or other ...