Edwards Lifesciences (NYSE:EW) shares rose 3.6% on Tuesday after the U.S. government released a proposed National Coverage Decision (NCD) memo concerning transcatheter aortic-valve replacement (TAVR).
The proposed NCD would extend coverage to patients with asymptomatic severe aortic stenosis under a coverage with evidence development framework. It would also remove the dual-operator intra-operative staffing requirement and eliminate a number of hospital-level volume requirements, among other eased restrictions.
Analysts responding to the proposal emphasized that the broadened asymptomatic coverage is a clear positive for Edwards Lifesciences. The market reaction included modest gains for competitors: Medtronic (NYSE:MDT) shares rose 0.91% and Abbott Laboratories (NYSE:ABT) shares increased 0.3% on the same news.
Evercore ISI analyst Vijay Kumar, who has an outperform rating on Edwards, described the memo as an extremely favorable outcome for the company: "This was an uber bullish scenario for EW. Every single key metric that the Bulls were hoping for was proposed." Kumar also noted that reduced volume requirements could permit the opening of additional TAVR centers.
Leerink Partners analyst Mike Kratky, who maintains a market perform rating on Edwards, said he is "incrementally positive on EW following the release of the TAVR NCD (National Coverage Decision) proposed decision memo." Kratky added, "These updates should enhance procedural efficiency at established TAVR centers and lower barriers to adoption for new programs."
Truist analyst Richard Newitter, who has a hold rating, said the proposal bolsters confidence in an 8%+ TAVR trajectory for Edwards Lifesciences into 2027 and supports continued share gains versus Medtronic and Boston Scientific. Newitter commented, "Narrative is on 'EW's side' and we see further runway up to our $90 PT."
The proposed NCD contains multiple provisions that analysts said could expand access and streamline operations for TAVR programs. Market participants will be watching for the final decision and any additional guidance that could affect rollout and center economics.