Edwards Lifesciences NYSE: EW raised its 2026 sales and earnings guidance after third-quarter results exceeded management’s expectations, with growth across its heart-valve businesses and regions.
The medical device maker reported sales of $1.72 billion, up 11.2% from a year earlier, and adjusted earnings of $0.80 per share. CEO Bernard Zovighian said the performance reflected continued strength in transcatheter aortic valve replacement, or TAVR, and growing contributions from the company’s mitral and tricuspid therapies.
Edwards now expects full-year sales growth of approximately 11.5% and adjusted earnings of $2.97 to $3.05 per share. At the midpoint, the earnings forecast represents 18% growth from the prior year, CFO Doretta Mistras said. The company’s growth commentary generally refers to underlying sales growth from continuing operations.
TAVR growth shifts toward procedure volumes
Third-quarter TAVR sales rose 8.8% to $1.2 billion, exceeding expectations. Zovighian said growth rates were similar in and outside the U.S., and average selling prices were stable globally.
Edwards raised its full-year TAVR growth forecast to 9% to 9.5%. Management expects future growth to come primarily from procedure volumes rather than market-share gains, as benefits from prior competitive changes have been absorbed.
Dan Lippis, Edwards’ global leader of TAVR, said the company had benefited for more than four quarters from Boston Scientific’s exit in Europe and other markets outside the U.S. in May 2025. That effect has now been fully annualized, he said, while Edwards’ competitive position has been sequentially stable over the past two quarters.
Zovighian told analysts that the change in the expected growth mix was not a signal that TAVR growth would slow next year. Edwards expects the U.S. Medicare coverage policy update and its asymptomatic indication to have a gradual effect over time, he said. The company plans to provide more detail on 2027 at its December investor conference.
Clinical data and coverage changes
Management highlighted the PROGRESS trial, which studied TAVR in patients with moderate aortic stenosis and at-risk features. Zovighian said the results support earlier intervention, while Lippis said identifying at-risk patients will require more advanced assessment than routine surveillance in many community settings.
Edwards does not yet have an indication for moderate aortic stenosis. Lippis declined to provide a specific regulatory timeline, saying the company expects to discuss its thinking more broadly at the investor conference.
Zovighian also pointed to an updated U.S. national coverage determination for TAVR. He said the policy expands coverage to asymptomatic patients, gives heart teams greater flexibility and provides a pathway for Medicare contractors to address coverage when future indications are approved.
Over the longer term, Edwards continues to target mid- to high-single-digit TAVR growth. Zovighian said the company expects some share loss over a 10-year horizon as competition increases, but expects market expansion to more than offset it.
Mitral and tricuspid therapies advance
Sales in Edwards’ transcatheter mitral and tricuspid therapies business rose 45.6% to $207 million. The company increased its full-year sales outlook for the business to $780 million to $790 million and reiterated its goal of reaching $2 billion in revenue in 2030.
Edwards recently received U.S. approval for PASCAL Precision to treat tricuspid regurgitation, completing its U.S. portfolio of mitral and tricuspid repair and replacement technologies. The company also received U.S. approval for PASCAL Ace with Capture Clarity for certain mitral repair procedures.
Zovighian said the CLASP II TR pivotal trial met its six-month primary endpoint, demonstrating the superiority of PASCAL plus optimal medical therapy over medical therapy alone in patients with severe or greater tricuspid regurgitation. He also cited positive clinical data for the EVOQUE tricuspid replacement system and SAPIEN M3 mitral replacement therapy.
Surgical sales increased 3% to $264 million, driven by adoption of the RESILIA portfolio. Edwards maintained its expectation for mid-single-digit full-year surgical sales growth.
Fourth-quarter outlook
For the fourth quarter, Edwards forecasts sales of $1.67 billion to $1.75 billion and adjusted earnings of $0.61 to $0.69 per share. Mistras said the company’s guidance is intended to be appropriate and credible and that it guides to the midpoint of its ranges.
Third-quarter GAAP earnings were $0.53 per share, primarily reflecting impairment of a research and development asset. Adjusted gross margin improved to 78.7% from 77.9% a year earlier, helped by manufacturing efficiencies and foreign exchange, Mistras said.
Edwards ended September with approximately $3.1 billion in cash and cash equivalents. It had repurchased approximately $700 million of shares through the third quarter, with roughly $1.3 billion remaining under its authorization.
About Edwards Lifesciences (NYSE:EW)
Edwards Lifesciences is a medical technology company focused on therapies for structural heart disease and critical care. Its products include transcatheter and surgical heart valves, as well as technologies used to monitor patients during intensive care and surgery.
The company traces its origins to 1958, when engineer Lowell Edwards and surgeon Albert Starr began developing an artificial heart valve. Their work led to the Starr-Edwards valve, introduced in 1960. Edwards Lifesciences is headquartered in Irvine, California, and serves clinicians and patients around the world.
Its structural heart portfolio includes transcatheter aortic valve replacement (TAVR) systems and therapies addressing mitral and tricuspid valve disease.
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