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Jun 16, 2026 4:00 PM

Edwards Lifesciences Stands Out As US Agency Eyes Broader Access For Heart Valve Device

On Monday, the Centers for Medicare & Medicaid Services (CMS) proposed removing the coverage with evidence development (CED) requirement for Transcatheter Aortic Valve Replacement (TAVR) in patients with symptomatic severe aortic stenosis.

William Blair on Tuesday wrote, "…this is a positive outcome for Edwards and largely validates the thesis we laid out following the NCD opening in December."

CMS Proposes Changes To TAVR Coverage Requirements

Aortic stenosis is a narrowing or stiffening of the heart's aortic valve. It restricts blood flow from the heart's main pumping chamber to the rest of the body.

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The agency also proposed expanding TAVR coverage to patients with asymptomatic severe aortic stenosis under CED and updating coverage criteria for pre-procedure evaluations, intraoperative standards, and operator and hospital volume ...