Edwards Lifesciences Releases Ten-Year Data on its Resilia Tissue

Edwards Lifesciences has announced 10-year results from the COMMENCE aortic trial, reinforcing the long-term durability and sustained performance of its proprietary RESILIA tissue.

The COMMENCE trial provides prospective, 10-year data demonstrating the durability of Edwards’ RESILIA tissue and its role in lifetime aortic stenosis management. 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

Long-term durability is important to patients 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, M.D., Ph.D., 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 developed structural heart solutions, 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, U.S. Food and Drug Administration (FDA)-approved studies such as the PARTNER trial series.

The PARTNER trial series reportedly 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 is 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,” Edwards Lifesciences CEO Bernard Zovighian stated. “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.

Edwards Lifesciences is a global structural heart innovation company developing technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders to deliver life-changing innovations to patients.