MDT News & Events

BTIG analyst Marie Thibault notes that the FDA's 510(k) database reflected clearance of Edwards Lifesciences' (EW) ECLIPTIS left atrial appendage exclusion system, which the analyst says is positioned to compete directly with AtriCure's (ATRC) open AtriClip platform and Medtronic's (MDT) Penditure system. The firm, which anticipates "a measured, targeted rollout," adding that AtriClip has already demonstrated an ability to fend off a surgical valve incumbent, citing the company having held share against Medtronic's Penditure since its launch. The firm is not adjusting its estimates for Edwards or AtriCure at this time, the analyst tells investors.

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.