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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 ...
Orange County Business Journal

FDA Clears Edwards Sapien 3 Valve

The Food and Drug Administration Wednesday approved Irvine-based Edwards Lifesciences Corp.’s Sapien 3 less-invasive heart valve. Sapien 3 is approved for patients with narrowing aortic heart valves ...
BioWorld

Edwards’ Sapien TAVR devices superior to SAVR in women

In the first study to compare transcatheter aortic valve replacement or implantation to surgical aortic valve replacement exclusively in women, Edwards Lifescience Corp.’s Sapien 3 and Sapien 3 Ultra ...
Seeking Alpha

Edwards TAVR Receives FDA Approval for Patients With Asymptomatic Severe Aortic Stenosis

IRVINE, Calif.--(BUSINESS WIRE)-- Edwards Lifesciences (EW) announced today that the U.S. Food and Drug Administration (FDA) has approved its transcatheter aortic valve replacement (TAVR) therapy, the ...