News

Fierce Biotech1h
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 ...
Orange County Business Journal2h
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.
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 ...
Healio3h
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 ...
MedPage Today4h
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 ...
TCTMD5h
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.
Single antiplatelet therapy reduced risk in patients undergoing transcatheter aortic valve replacement by half
Findings from the Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) registry demonstrate that ...
MassDevice5h
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.
Edwards TAVR Receives FDA Approval for Patients With Asymptomatic Severe Aortic Stenosis
Edwards Lifesciences (NYSE: EW) announced today that the U.S. Food and Drug Administration (FDA) has approved its transcatheter aortic valve replacement (TAVR) therapy, the SAPIEN 3 platform, for ...