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

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.

Schreibe Deinen Kommentar