Edwards said study data supporting earlier use of its Sapien heart valves to treat patients who have severe aortic stenosis without symptoms is changing clinical practice and helping to accelerate sales of the devices.
The company on Tuesday posted a second consecutive quarter of double-digit sales growth in its transcatheter aortic valve replacement business.
CEO Bernard Zovighian said momentum is coming from long-term data presented last fall confirming the durability of the Sapien valves and the “practice-changing” EARLY TAVR trial results that showed asymptomatic patients who had the procedure fared better than those who remained under clinical surveillance alone. Edwards is the only TAVR system with asymptomatic approval.
On the fourth-quarter call, Zovighian pointed to new European medical society guidelines that lowered the recommended age for TAVR to 70 years from 75 and said physicians are moving away from the “outdated” practice of watchful waiting in aortic stenosis cases.
“While EARLY TAVR studied TAVR [aortic stenosis] patients without symptoms, we are encouraged by the impact this study has had on increasing the sense of urgency for the treatment of patients who have symptoms,” Zovighian said.
In the U.S., Edwards is awaiting an updated national coverage determination from the Centers for Medicare and Medicaid Services. The company in July asked the CMS to extend coverage to Medicare beneficiaries with asymptomatic severe aortic stenosis. The CMS is now reviewing the request, and a final decision could come in the fourth quarter, Edwards executives said on the call.
Edwards’ TAVR rebound follows a slowdown in sales over the past two years that the company attributed to hospital capacity challenges and has been working with providers to address. Executives on the call emphasized increased confidence in meeting the company’s forecast for 2026 sales growth in a range of 8% to 10% in constant-currency terms.
TMTT portfolio
Edwards said it continues to expand the number of centers supporting global adoption of its Pascal valve repair devices and Evoque tricuspid valve replacement devices. A next-generation version of Pascal and the U.S. introduction of Pascal for tricuspid valve patients are expected in the fourth quarter, Zovighian said.
The company is also introducing Sapien M3, a mitral regurgitation treatment, in the U.S. and Europe.
