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

The Centers for Medicare & Medicaid Services (CMS) proposed removing coverage with evidence development (CED) requirements for Transcatheter Aortic Valve Replacement (TAVR) in symptomatic severe aortic stenosis patients and expanding coverage to asymptomatic cases under CED. Edwards Lifesciences, which holds the only FDA-approved TAVR device for asymptomatic severe aortic stenosis, stands to gain a competitive advantage from these proposed changes. The stock rose 3.74% to $88.65 following the announcement.