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 ...
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 ...
Medical Xpress6d
Early transcatheter aortic valve replacement reduces cardiovascular events in asymptomatic aortic stenosis patients
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.
Yahoo Finance6d
FDA approves Edwards’ TAVR system for asymptomatic aortic stenosis patients
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 ...
KTEN3d
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 ...
Nasdaq6d
Edwards Lifesciences Says FDA Approved TAVR Therapy For Asymptomatic Severe Aortic Stenosis
for severe aortic stenosis (AS) patients without symptoms. Approval of the SAPIEN 3 platform (SAPIEN 3, SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA) is based on positive results from the EARLY TAVR ...