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.
Expanded Medicare coverage
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.
“Putting it all together, there is robust evidence and emerging indication validating the patient benefits of proactive disease management for AS, and with the opportunity that comes from the modernized NCD in the U.S., we have reinforced confidence in the durable mid- to high-single-digit growth of our Sapien platform over the long term,” the CEO said.
Edwards raised its 2026 sales growth forecast to about 11.5% on a constant currency basis, up from a prior range of 10% to 11%, based on the third-quarter TAVR strength. The company also boosted its outlook for sales growth in the transcatheter mitral and tricuspid therapies business to a range of $780 million to $790 million, from $760 million to $780 million previously.
The momentum follows two years in which Edwards saw sales slow due to hospital capacity challenges.
Marie Thibault, analyst at U.S. Bancorp BTIG, believes Edwards’ TAVR business has stabilized.
“Looking ahead, TAVR revenue growth is expected to be driven primarily by procedure volumes; we see plenty of opportunity here with the aortic stenosis market clearly underpenetrated,” Thibault said Wednesday in a note to investors.
In recent quarters, Edwards has benefited from modest share gains, company executives said, after competitor Boston Scientific exited the market outside the U.S. Zovighian said growing procedure volumes would drive growth going forward. “We are very confident about the years to come,” he said.
