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FDA approves Edwards’ TAVR system for asymptomatic aortic stenosis patients

The US Food and Drug Administration (FDA) has approved Edwards Lifesciences' SAPIEN 3 transcatheter aortic valve replacement (TAVR) platform for the treatment of patients with asymptomatic severe ...
FierceBiotech

Edwards Lifesciences nets FDA approval opening up TAVR to patients before they show symptoms

Edwards Lifesciences has claimed a groundbreaking approval from the FDA that opens up its minimally invasive heart valve implants to patients before they begin to show cardiac symptoms. The company ...
Orange County Business Journal

FDA Approves New Indication for Edwards’ TAVR Platform

Edwards Lifesciences Corp. today announced that it received Food and Drug Administration approval for its Sapien 3 platform in asymptomatic patients with severe aortic stenosis. It marks the first ...
Nasdaq

Edwards SAPIEN 3 TAVR Delivers Proven Long-term Benefits and Valve Performance, New Data Presented at TCT 2025

SAN FRANCISCO--(BUSINESS WIRE)-- Edwards Lifesciences (NYSE: EW) today announced seven-year data from the PARTNER 3 trial, reaffirming the early and sustained patient benefits of Edwards TAVR. The ...