Edwards Raises 2026 Forecast on TAVR Strength
The medical device maker lifted its full-year sales outlook for a third time this year, citing strong demand for its heart valve therapies.
Updated on Nov. 5, 2026 in Heart Disease
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Should patients with moderate heart valve disease get treatment before symptoms appear?
Edwards Lifesciences raised its 2026 sales growth forecast to about 11.5% on a constant currency basis, up from a prior range of 10% to 11%, after third-quarter sales exceeded its expectations. The company also boosted its transcatheter mitral and tricuspid therapies outlook to $780 million to $790 million.
Why it matters
The forecast increase reflects renewed momentum in transcatheter aortic valve replacement, supported by new clinical data and expanded Medicare coverage. Sales had slowed over two years amid hospital capacity constraints, making the upgrade a signal of recovery for the company.
Edwards' revised guidance is company-reported and reflects a constant currency growth forecast of about 11.5%, compared with the prior 10% to 11% range. The forecast does not yet reveal how much of the increase will persist if hospital capacity constraints return.
The players
Edwards Lifesciences
A U.S.-based medical technology company focused on structural heart disease, known for its Sapien line of transcatheter heart valves.
Boston Scientific
A large U.S. medical device manufacturer that exited the transcatheter valve market outside the United States, allowing Edwards to gain modest share.
Centers for Medicare and Medicaid Services
The federal agency that administers Medicare and sets national coverage policy, including the final TAVR coverage determination released this quarter.
The details
The upgrade follows positive results from the PROGRESS trial, presented at the Transcatheter Cardiovascular Therapeutics conference, which showed Sapien 3 TAVR was superior to standard clinical surveillance in patients with moderate aortic stenosis and at-risk features. The Centers for Medicare and Medicaid Services also released a final national coverage determination extending TAVR coverage to asymptomatic patients with severe aortic stenosis.
Timeline
April 2025: The FDA approved an expanded Sapien 3 indication for asymptomatic severe aortic stenosis patients.
Third quarter 2026: CMS released its final TAVR coverage determination, and Edwards reported strong quarterly sales.
November 5, 2026: Edwards raised its full-year forecast during its earnings call.
Big Picture
The updated CMS determination extends the national Medicare coverage framework for TAVR to asymptomatic patients with severe aortic stenosis, widening the population eligible for the procedure. This follows the FDA's April 2025 expansion of Sapien 3's approved indication, which together reflect a broader movement toward treating valve disease earlier.
Patients with severe aortic stenosis who have no symptoms may now qualify for TAVR coverage under the updated Medicare determination. Those considering the procedure should discuss eligibility and reimbursement with their cardiologist and insurer.
The takeaway
Expanded coverage and earlier-stage clinical data suggest TAVR will be offered to a wider group of patients with aortic stenosis. Patients should ask their doctor whether monitoring or intervention is appropriate for their stage of disease.
Further reading
Explore more on Heart Disease coverage across the United States.
Live Poll
Should patients with moderate heart valve disease get treatment before symptoms appear?
