Ten-Year Pivotal Data Demonstrate Long-Term Durability of Edwards Lifesciences’ Resilia Tissue

Key Terms

aortic stenosis medical

Aortic stenosis is a narrowing of the heart’s aortic valve that makes it harder for blood to leave the heart, similar to a door that won’t open fully or a garden hose with a pinched end. It matters to investors because the condition drives demand for diagnostic tests, medicines, surgical procedures and medical devices; changes in treatment options, clinical trial results or regulatory approvals can quickly affect the revenue and valuation of companies in the healthcare and medical-device sectors.

structural heart medical

Structural heart describes medical devices and treatments that fix or replace the heart’s valves, walls, chambers and other physical parts — essentially the mechanical “plumbing and doors” of the heart rather than electrical or artery-focused care. It matters to investors because advances, regulatory approvals, and shifts from open surgery to less invasive procedures can quickly change sales, profit margins and adoption rates for companies that make these devices, much like a new, more efficient tool reshaping a repair market.

hemodynamic performance medical

Hemodynamic performance describes how well a medical device or treatment moves and controls blood flow and pressure inside the body, like judging a pump and its pipes for steady water flow. Investors care because better hemodynamic results usually mean safer, more effective products that win regulatory approval, clinician adoption and insurance coverage, all of which affect sales, liability and long‑term value.

transcatheter medical

Transcatheter describes medical procedures or devices delivered through a thin, flexible tube (catheter) that is threaded through blood vessels or small body openings to reach the heart or other organs without open surgery. It matters to investors because transcatheter approaches enable faster recovery, shorter hospital stays and larger patient pools for treatments that once required major operations, which can expand market demand and affect device and hospital revenues.

biological valves medical

Biological valves are heart valve replacements made from animal or human tissue that act like a flexible door flap to keep blood flowing in the right direction. Investors pay attention because these devices drive sales, regulatory reviews, and repeat procedures based on how long they last and how well they work—factors that affect a medical device maker’s revenue, costs and growth prospects.

structural valve deterioration medical

Structural valve deterioration is the gradual wear, damage or hardening of an implanted heart valve that causes it to narrow or leak over time, reducing how well it controls blood flow. For investors, it matters because the rate and timing of such failures determine how long devices last, influence demand for replacements or repairs, affect regulatory labeling and reimbursement, and can drive warranty costs or liability — similar to how product durability shapes a company’s repair and replacement business.

non-structural valve dysfunction medical

Non-structural valve dysfunction is when an implanted heart valve fails to work properly even though its physical parts are intact, for example because of clotting, improper positioning, tissue overgrowth, or leakage around the valve. Think of a door whose hinges are fine but that still sticks or lets drafts through—function is impaired without broken hardware. Investors care because this type of complication can affect device safety records, regulatory reviews, clinical adoption, liability exposure, and future sales.

bioprosthetic valve medical

A bioprosthetic valve is a heart valve replacement made from biological tissue (usually animal or human) mounted on a supporting frame to restore normal blood flow. For investors, it matters because these devices drive revenue through surgeries, follow-up care and replacement cycles, and their value depends on clinical performance, durability, regulatory approvals and patient demand—similar to how a reliable spare part can influence sales and service needs for a durable-goods product.

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CHICAGO--(BUSINESS WIRE)-- Edwards Lifesciences (NYSE: EW) today announced 10-year results from the COMMENCE aortic trial, reinforcing the long-term durability and sustained performance of its proprietary RESILIA tissue. The data were presented at the 106th American Association for Thoracic Surgery Annual Meeting.

As evidence increasingly supports treating patients earlier in the valve disease pathway, the need for durable valve solutions continues to grow. The COMMENCE trial provides prospective, 10-year data demonstrating the durability of Edwards’ RESILIA tissue and its role in lifetime management for patients with aortic stenosis. To date, more than 500,000 patients worldwide have been treated with Edwards’ surgical and transcatheter innovations featuring RESILIA tissue.

At 10 years, COMMENCE trial data showed that patients treated with Edwards’ surgical valves featuring RESILIA tissue experienced:

• 97.9% freedom from structural valve deterioration (SVD)
• 97.8% freedom from reoperation due to SVD
• 98.6% freedom from non-structural valve dysfunction (other than PVL)
• Sustained hemodynamic performance, including stable gradients and effective orifice area over time

For patients, long-term durability matters because it can reduce the likelihood of repeat procedures over a lifetime, helping preserve quality of life as life expectancy increases.

“These 10-year data from the COMMENCE trial suggest this tissue technology has the potential to change the way we think about durability in biological valves, including in younger patients,” said Lars G. Svensson, MD, PhD, chief of the Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute and professor of surgery at Cleveland Clinic. “What is striking is the low rate of structural valve deterioration and need for reoperation, even though the trial enrolled younger patients who historically face higher risks of valve deterioration, underscoring the importance of long-term evidence when physicians are making treatment decisions with their patients.”

For nearly 70 years, Edwards has led structural heart innovation, advancing evidence generation that has helped set the standard for evaluating valve performance, durability and treatment options in severe aortic stenosis. The COMMENCE trial builds on the totality of Edwards’ clinical evidence, reinforcing the durability of outcomes supporting its surgical and transcatheter therapies, including large, randomized, FDA-approved studies such as the PARTNER series of trials.

The PARTNER trial series advanced the field with long-term patient outcomes on treatment with SAPIEN TAVR and SAVR, with 10 years of follow-up data. The new COMMENCE trial data build on that foundation with the latest evidence on the long-term durability of RESILIA tissue.

RESILIA tissue was designed to enhance the durability of tissue valves by helping resist calcification, a leading cause of valve failure over time. The technology combines advanced calcium blocking processes with dry storage to support long-term valve performance.

“As patients live longer and expect to remain active, structural heart therapies must be designed with lifetime care in mind,” said Bernard Zovighian, Edwards’ CEO. “The COMMENCE 10-year study is the latest addition to our breadth of long-term data reflecting our commitment to advancing durable valve technologies through continuous evidence development, so Heart Teams and patients can make informed decisions over time.”

The COMMENCE aortic trial is an FDA-approved, pivotal, prospective, multicenter clinical study designed to evaluate the safety and effectiveness of a bioprosthetic valve with RESILIA tissue used in SAVR, with follow-up through 10 years. Safety endpoints were defined according to established guidelines and independently adjudicated.

About Edwards Lifesciences

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. Discover more at www.edwards.com and follow us on LinkedIn, Facebook, Instagram and YouTube.

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, but are not limited to, statements made by Mr. Zovighian and statements regarding expected long-term durability and sustained performance, reduction of the likelihood of repeat procedures, therapies helping to preserve quality of life, outcomes of the surgical and transcatheter therapies, expectations for remaining active, and other statements that are not historical facts. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made, and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. Investors are cautioned not to unduly rely on such forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors as detailed in the company's filings with the Securities and Exchange Commission. These filings, along with important safety information about our products, may be found at Edwards.com.

Edwards, Edwards Lifesciences, the stylized E logo, COMMENCE, PARTNER, RESILIA, and SAPIEN are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260502326120/en/

Media: Maureen Ranney, media@edwards.com
Investors: Gerianne Sarte, investor_relations@edwards.com

Source: Edwards Lifesciences Corporation