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