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

CMS's updated TAVR coverage policy provides greater flexibility for patient evaluations, procedure staffing and hospital program requirements, potentially enabling 100–200 additional U.S. centers to offer TAVR over time. Edwards expects durable mid- to high-single-digit TAVR growth.

Edwards is targeting more than $2 billion in TMTT revenue by 2030 , supported by PASCAL, EVOQUE and SAPIEN M3. The business is expected to generate approximately $250 million in 2026 revenue, with about 40% growth, while PASCAL tricuspid approval could provide another catalyst.

The company expects results from its PROGRESS trial in moderate aortic stenosis in roughly six weeks, which could expand the TAVR opportunity if earlier treatment proves beneficial. Edwards also aims for approximately 10% long-term revenue growth across its five structural-heart therapy platforms.

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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.

CMS Coverage Decision Expands TAVR Flexibility

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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.