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
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.
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 outcomes or the market implications of different trial results.
He said Edwards launched the study based on its belief that treating aortic stenosis patients earlier, before further disease progression, could be beneficial. The study enrolled quickly, which he described as an encouraging sign of physician interest. However, he emphasized that the trial evaluates only the most severe moderate patients with at least one risk factor.
While acknowledging the potential size of the moderate patient population, Zovighian said it is difficult to precisely estimate the total addressable market before patients are broadly identified and treated. Mistras added that penetration in Edwards’ existing market remains in the low teens, leaving meaningful opportunity even without additional indications.
TMTT Portfolio Targets Further Growth
For transcatheter mitral and tricuspid therapies, or TMTT, Zovighian said Edwards is focused on PASCAL for mitral regurgitation, PASCAL for tricuspid regurgitation, EVOQUE and SAPIEN M3. He said the business is on track for roughly $250 million in revenue and approximately 40% growth in 2026.
The company remains focused on its previously stated goal of more than $2 billion in TMTT revenue by 2030, though Zovighian said Edwards’ longer-term ambition is broader than that target. He cited millions of patients with mitral and tricuspid disease who lack treatment options.
Edwards expects a PASCAL tricuspid approval before year-end, which Zovighian said would add an incremental growth opportunity. EVOQUE is expanding through both new-center openings and increased utilization at existing centers, while SAPIEN M3 is in the early stages of its commercial launch following approval earlier this year, he said.
On tricuspid disease, Zovighian said the category remains early in its development because physicians had few options until recently. He pointed to the TRIC-I-HF study from German centers as evidence of progress in the field’s understanding, noting that the study showed a mortality benefit in addition to quality-of-life benefits.
Capital Allocation and Long-Term Focus
Mistras said Edwards’ first capital-allocation priority is investment in internal capabilities, including its manufacturing network. The company also plans to evaluate external opportunities that fit its structural-heart strategy and allow Edwards to participate early in development. As a third priority, she said Edwards will continue to repurchase shares opportunistically, noting that it had bought back more than $500 million of stock year to date.
Zovighian said the company’s long-term target is to grow revenue by about 10%, supported by catalysts across its five therapy areas. He also said artificial intelligence could increasingly help hospitals improve disease awareness, imaging analysis, diagnostics and treatment decisions over the coming years.
About Edwards Lifesciences (NYSE:EW)
Edwards Lifesciences Corporation (NYSE:EW) is a medical technology company focused on therapies for structural heart disease. Its products are designed to treat conditions affecting the heart valves and related cardiovascular structures, helping patients with diseases such as aortic stenosis, mitral regurgitation and tricuspid valve disorders.
The company’s portfolio includes transcatheter aortic valve replacement systems, including its SAPIEN platform, as well as transcatheter mitral and tricuspid therapies and surgical heart valve products.
