EW News & Events

The Centers for Medicare and Medicaid Services released a national coverage analysis, proposing to cover transcatheter aortic valve replacement for symptomatic severe aortic valve stenosis without the coverage with evidence development requirement, expand coverage of TAVR to asymptomatic severe aortic stenosis, and revise coverage criteria related to pre-procedural patient assessment, intraoperative requirements, and operator and hospital procedural volume requirements. The CMS proposed that TAVR for severe aortic stenosis is covered when furnished with a complete aortic valve and implantation system that has received Food and Drug Administration premarket approval for that system's FDA-approved indication. Shares of Edwards Lifesciences are up 3% to $89.23 in premarket trading.

TD Cowen says last night's proposed Centers for Medicare and Medicaid Services transcatheter aortic valve replacement national coverage analysis "represents one of the most important positive policy developments for the structural heart market in years." By expanding coverage to asymptomatic severe aortic stenosis patients, eliminating the requirement for dual-operator procedures, and reducing barriers for new TAVR programs, the proposal could accelerate TAVR adoption in the U.S., the analyst tells investors in a research note. TD believes Edwards Lifesciences (EW) is best positioned to benefit. The stock in premarket trading is up 3% to $89.02. Medtronic (MDT) and Abbott (ABT) are slightly higher.