Edwards Lifesciences presented new data at New York Valves 2026, reinforcing its leadership in advancing high-quality scientific evidence for structural heart therapies. The data, spanning aortic, mitral, and tricuspid therapies, provide insights into the complexity of structural heart disease and the need for innovative treatment options. The findings were presented at the annual conference organized by the Cardiovascular Research Foundation.

PROGRESS Trial Baseline Characteristics

The baseline characteristics of the PROGRESS trial offer new insights into the heterogeneous nature of moderate aortic stenosis (AS) patients. The trial evaluates whether patients with moderate AS and at least one risk factor may benefit from transcatheter aortic valve replacement (TAVR) earlier than current guidelines. Key characteristics include:

SAPIEN Platform Durability and EARLY TAVR Findings

Late-breaking clinical science presentations strengthen the evidence base for the SAPIEN 3 platform. This includes seven-year benchmark durability data from the PARTNER 3 trial, simultaneously published in JAMA Cardiology. New findings from the EARLY TAVR trial reinforce the shift toward proactive disease management, providing long-term reassurance for physicians and patients.

Mitral and Tricuspid Portfolio Outcomes

New data highlighted clinical trial and real-world outcomes across Edwards’ mitral and tricuspid portfolio. Data from more than 4,500 patients treated with the PASCAL system in the STS/ACC Transcatheter Valve Therapy Registry demonstrate sustained safety and effectiveness for mitral regurgitation (MR). One-year data from the ENCIRCLE trial Mitral Annular Calcification (MAC) Registry support the safety, effectiveness, and quality of life improvements with SAPIEN M3, the first transcatheter transseptal mitral valve replacement system.

Bernard Zovighian, Edwards’ CEO, emphasized the company's commitment to addressing unmet needs and advancing care through partnerships with the physician community. The expanding evidence base aims to strengthen confidence in long-term outcomes and increase access for patients worldwide.

The Centers for Medicare & Medicaid Services (CMS) proposed removing the coverage with evidence development (CED) requirement for Transcatheter Aortic Valve Replacement (TAVR) in patients with symptomatic severe aortic stenosis. This move aims to broaden access to the heart valve device, a significant development for Edwards Lifesciences Corp. The proposal also includes expanding TAVR coverage to asymptomatic severe aortic stenosis patients under CED and updating coverage criteria for pre-procedure evaluations, intraoperative standards, and operator and hospital volume requirements.

William Blair analyst Brandon Vazquez described the update as a win for Edwards Lifesciences, noting it validates the thesis following the National Coverage Determination (NCD) opening in December. The proposal aligns with the EARLY TAVR data and the FDA's April 2025 expansion of the SAPIEN 3 label. Edwards currently holds the only FDA-approved TAVR device indicated for asymptomatic severe aortic stenosis patients, positioning the company for a competitive advantage if the coverage is finalized.

CMS Proposes Changes To TAVR Coverage Requirements

Aortic stenosis involves the narrowing or stiffening of the heart's aortic valve, restricting blood flow from the heart to the body. The CMS proposal seeks to simplify the treatment pathway and enable patients to access therapy sooner. The continued data collection under CED for asymptomatic patients is expected to benefit stakeholders across the healthcare system.

Analyst Views CMS Proposal As Positive For Edwards Lifesciences

William Blair maintains an Outperform rating for Edwards Lifesciences. The implementation of the NCD could catalyze TAVR adoption by streamlining the treatment process. Edwards Lifesciences shares were up 3.74% at $88.65 at the time of publication on Tuesday, reflecting market optimism about the proposed changes.