Wider Medicare Coverage Expands Aortic Valve Access

Adults with aortic stenosis, including some without symptoms, may now qualify for a catheter-based valve replacement under expanded coverage.

Updated on Nov. 5, 2026 in Heart Disease

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Edwards Lifesciences raised its 2026 sales forecast to about 11.5% growth as wider Medicare coverage expands access to catheter-based aortic valve replacement. AI Illustration. Upload story photo >

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Should patients with moderate heart valve disease get treatment before symptoms appear?

Edwards Lifesciences raised its 2026 full-year sales forecast for the third time this year, after third-quarter sales exceeded its expectations. The company now projects about 11.5% constant-currency sales growth, up from a prior range of 10% to 11%, with growth driven largely by its transcatheter aortic valve replacement (TAVR) business in the United States.

Why it matters

The raised outlook reflects stronger demand for TAVR, a minimally invasive procedure that replaces a narrowed aortic valve, and wider Medicare coverage that can make the procedure available to more patients. Improved access and new trial evidence signal that treatment decisions for aortic valve disease are shifting earlier in the disease course.

The forecast increase rests on third-quarter results and on the PROGRESS trial, which found Sapien 3 TAVR superior to standard clinical surveillance in people with moderate aortic stenosis who have at-risk features. Sales growth figures are company-reported guidance, and the source does not detail the trial's sample size or follow-up duration.

The players

Edwards Lifesciences

A medical device company that specializes in structural heart therapies, including the Sapien TAVR valve for aortic stenosis.

Centers for Medicare and Medicaid Services

The federal agency that sets national Medicare coverage rules, including the final national coverage determination for TAVR.

Food and Drug Administration

The federal agency that approves medical devices and drugs, including the April 2025 expanded indication for Sapien 3.

Boston Scientific

A medical device maker with cardiovascular products that exited the TAVR market outside the United States, according to the source.

The details

Aortic stenosis is a narrowing of the valve that controls blood flow from the heart to the body, and TAVR places a replacement valve through a catheter rather than requiring open-heart surgery. The PROGRESS results were presented at the Transcatheter Cardiovascular Therapeutics conference and support earlier intervention in patients with moderate disease who have risk features. The updated Medicare national coverage determination extends coverage to patients with severe aortic stenosis who have no symptoms, following FDA approval in April 2025 of an expanded Sapien 3 indication for that group.

Timeline

  1. April 2025: FDA approved an expanded Sapien 3 indication for asymptomatic severe aortic stenosis.

  2. Third quarter 2026: CMS released its final national coverage determination for TAVR, and Edwards reported strong quarterly sales.

  3. November 5, 2026: Edwards raised its full-year forecast on its earnings call.

Health Landscape

TAVR has become a central option for patients with aortic stenosis who are considered too high-risk for open-heart valve surgery, and coverage expansions move it earlier into the disease course. The shift toward treating moderate and asymptomatic disease reflects a broader trend in cardiology toward intervening before symptoms become severe.

If you have been told you have aortic stenosis, ask your cardiologist whether your current stage makes you a candidate for monitoring or intervention, since trial evidence now supports earlier treatment in some patients. Coverage changes may affect access, so it is worth asking your care team how Medicare coverage applies to your situation.

The takeaway

Expanded evidence and coverage are moving TAVR earlier in aortic stenosis care, which makes it a valid topic to raise with your heart doctor if you have been diagnosed with the condition. Ask your cardiologist how the current stage of your valve disease should guide monitoring and treatment timing.

Further reading

For more on how valve treatments are evolving, explore our Heart Disease coverage.

Source note: This article includes information reported by MedTech Dive.

Live Poll

Should patients with moderate heart valve disease get treatment before symptoms appear?