Edwards Lifesciences Sees TAVR Expansion, $2B TMTT Opportunity Ahead

Edwards Lifesciences NYSE: EW outlined a strategy centered on structural heart disease, with Chief Executive Officer Bernard Zovighian highlighting five therapy areas that the company views as its principal growth platforms: transcatheter aortic valve replacement for aortic stenosis, PASCAL, EVOQUE, SAPIEN M3 and surgical therapies. Zovighian said the company’s focus on structural heart disease provides “strategic clarity” in a large and growing market with significant unmet patient need. He said Edwards’ approximately 17,000 employees are driven by the company’s patient-focused mission, while its leadership team is concentrated on execution in structural heart disease. Get Edwards Lifesciences alerts: Sign Up CMS Coverage Decision Expands TAVR Flexibility Beyond Biotech—3 Healthcare Stocks for Growth-Minded Investors A central topic of the discussion was the recent Centers for Medicare & Medicaid Services National Coverage Determination, or NCD, for TAVR. Zovighian characterized the decision as positive for patients, the field and Edwards, saying CMS determined that the therapy is “reasonable and necessary” following years of clinical evidence and physician experience. He identified four major elements of the updated policy: Greater flexibility in patient evaluation, including one required in-person physician visit rather than two. Greater flexibility during procedures, with one required operator rather than a mandatory surgeon and cardiologist both present in the room. Removal of hospital procedure-volume requirements to establish a TAVR program, while operator requirements remain in place. Coverage with evidence development for asymptomatic patients and a pathway for Medicare Administrative Contractor coverage of future FDA-approved indications. 3 Healthcare Pathbreakers With Long-Term Tailwinds Edwards estimates there are roughly 1,100 cardiac surgery centers in the U.S., compared with about 850 existing TAVR centers. Zovighian said the gap represents a potential opportunity for some cardiac surgery centers to open TAVR programs, though he does not expect all of them to do so. He estimated that perhaps 100 to 200 new centers could ultimately open, with adoption occurring over time as hospitals make decisions, receive approvals and train staff. Chief Financial Officer Doretta Mistras said the coverage changes create multi-year opportunities rather than a near-term surge followed by a decline. She said the company continues to expect durable TAVR growth in the mid- to high-single-digit range. Moderate Aortic Stenosis Trial Nears Results Zovighian also discussed the company’s PROGRESS trial in moderate aortic stenosis, with results expected in approximately six weeks at the TCT meeting. He declined to speculate about potential...