FDA Approves Sapien 3 TAVR for Asymptomatic Aortic Stenosis

FDA Approves Sapien 3 TAVR for Asymptomatic Aortic Stenosis

(MedPage Today) -- 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 indication for aortic valve replacement...

Younger Patients with Asymptomatic Aortic Stenosis who Undergo TAVR Experience Fewer Serious Cardiovascular Events

According to a presentation at the SCAI 2025 Scientific Sessions, analysis from EARLY TAVR trial shows early TAVR correlates to lower risk of death, stroke, or heart failure hospitalization compared to clinical surveillance across patients aged 65-80.

FDA Approves New Indication for Edwards’ TAVR Platform - Orange County Business Journal

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 approved transcatheter aortic valve replacement therapy in asymptomatic patients, according to the company. “There is an urgent need to change practice and TAVR guidelines for the treatment of aortic stenosis patients, which currently recommend ‘watchf…

FDA approves Edwards’ TAVR system for asymptomatic aortic stenosis patients

The FDA has approved Edwards Lifesciences' SAPIEN 3 TAVR platform for the treatment of patients with asymptomatic severe aortic stenosis (AS).The post FDA approves Edwards’ TAVR system for asymptomatic aortic stenosis patients appeared first on Medical Device Network.

Edwards’ Sapien 3 lands US FDA approval for the treatment of asymptomatic severe AS - Cardiovascular News

Sapien 3 Ultra Edwards Lifesciences has announced that the US Food and Drug Administration (FDA) has approved its Sapien 3 transcatheter aortic valve implantation (TAVI) platform for the treatment of severe aortic stenosis (AS) patients without symptoms, marking the first FDA approval for TAVI in asymptomatic patients. Approval of the Sapien 3 platform (Sapien 3, Sapien 3 Ultra and Sapien 3 Ultra Resilia) is based on data from the EARLY TAVR tri…