Going forward, the heart valve maker expects procedure volumes to rise following positive study data and expanded Medicare reimbursement.
Edwards Lifesciences’ third-quarter sales exceeded its expectations, prompting the heart valve maker to raise its full-year forecast for the third time this year.
Executives on Wednesday’s earnings call pointed to several catalysts for the business going forward, including data supporting expanded use of transcatheter aortic valve replacement to treat aortic stenosis.
In the PROGRESS trial, presented this week at the Transcatheter Cardiovascular Therapeutics conference, Edwards’ Sapien 3 TAVR device demonstrated superiority to standard-of-care clinical surveillance in people with moderate aortic stenosis and at-risk features.
The results mark a “turning point” for many patients, CEO Bernard Zovighian told investors, with the evidence backing intervention before the disease progresses to avoid significant health decline and heart failure.
“These findings challenge the long-standing assumption that moderate AS patients can be managed by the current practice of passive surveillance,” Zovighian said.
A final national coverage determination for TAVR from the Centers for Medicare and Medicaid Services, released during the quarter, is another step toward increasing patient access to the procedure, Zovighian said. The updated policy extends Medicare coverage to patients who already have severe disease but without symptoms. Based on the company’s EARLY TAVR study results, Edwards won Food and Drug Administration approval in April 2025 for an expanded indication for Sapien 3 in severe aortic stenosis patients who are asymptomatic.
, we have reinforced confidence in the durable mid- to high-single-digit growth of our Sapien platform over the long term,” the CEO said.
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