A victory for early treatment: FDA approves first TAVR valves for asymptomatic severe aortic stenosis

Sapien 3 Ultra Resilia TAVR valves

The SAPIEN 3 Ultra Resilia TAVR valve is available in multiple sizes. Images courtesy of Edwards Lifesciences. 

The FDA has approved the balloon-expandable Sapien 3 TAVR platform from Edwards Lifesciences for treating asymptomatic severe aortic stenosis. This is the first time the agency has approved any TAVR technology to be used in asymptomatic patients.