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.

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 ...

In the EARLY TAVR trial, which informed the approval, patients with asymptomatic severe aortic stenosis were randomly assigned to either TAVR or watchful waiting. During a median follow-up of 3.8 ...

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 ...

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 ...

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 ...

In patients greater than age 65, more than 90% of aortic stenosis involves trileaflet valves which have developed heavy calcification. [5] In these instances the calcium deposits are thought to ...