EDWARDS MITRIS RESILIA VALVE RECEIVES CE MARK FOR MITRAL REPLACEMENT SURGERIES

Edwards MITRIS RESILIA VALVE RECEIVES CE MARK FOR MITRAL REPLACEMENT SURGERIES

The MITRIS RESILIA valve is made with innovative tissue technology RESILIA allowing the valve to potentially last longer than conventional bioprosthetic valves.*

NEWBURY, UK, October 31^st, 2023 -- Edwards Lifesciences today announced it received CE Mark for the MITRIS RESILIA valve, a tissue valve replacement specifically designed for the heart's mitral position. The MITRIS RESILIA valve is made with innovative bovine pericardial tissue technology that reduces calcium build up on the valve. This technology preserves and protects the tissue, allowing the valve to potentially last longer than conventional bioprosthetic valves.*

The MITRIS RESILIA valve has a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve. The low-profile valve is based on the Edwards PERIMOUNT valve design with a nitinol wireform, which allows it to fold inward during implantation. The MITRIS RESILIA valve is visible under fluoroscopy, which facilitates potential future transcatheter interventions for patients.

Recent data on the RESILIA tissue from the COMMENCE aortic trial reported encouraging results with low rates of structural valve deterioration (99.3% freedom from structural valve deterioration), clinically stable gradients and freedom from reoperation (97.2%) through seven years. Additionally, the COMMENCE mitral trial demonstrated clinically stable hemodynamics and freedom from structural valve deterioration (98,7%) at 5 years.

The RESILIA anti-calcification technology also allows devices to be stored under dry packaging conditions, facilitating ease of use.

“Mitral valve disease is common and patients experience the disease in various ways. When it comes to patients in need of mitral valve replacement, the advanced MITRIS RESILIA valve, which mimics the native valve and is based on the trusted pericardial PERIMOUNT, is underpinned by a crucial integrity-preservation technology incorporated in the RESILIA tissue”. Says Toufan Bahrami MD EBCTS, Consultant Cardiac Surgeon and Mitral and Aortic Valve Specialist, Guy's and St Thomas' NHS Foundation Trust. “This technology has the potential to enhance the valve's durability, addressing the growing importance of longevity in valve performance.”

Edwards is dedicated to partnering with clinicians to develop patient-centric innovations for complex surgical structural heart procedures that improve long-term care and outcomes for patients.

“Edwards Lifesciences is committed to addressing the needs of patients with structural heart disease,” says Nick Walker, Senior Country Director at Edwards Lifesciences UK and Ireland. “Our RESILIA tissue technology is designed for enhanced durability, supporting improved quality of life for patients and relieving the burden on healthcare systems.”

The MITRIS RESILIA valve received FDA approval in 2022 in the United States. The introduction of the MITRIS RESILIA valve into the portfolio demonstrates Edwards’ continuous investment in innovation for the benefits and the quality of life of patients.

About Edwards Lifesciences

Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakeholders across the global healthcare landscape. For more information, visit Edwards.com and follow us on LinkedIn and Twitter.

Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, Carpentier-Edwards PERIMOUNT, MITRIS, MITRIS RESILIA, PERIMOUNT, and RESILIA are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. This statement is made on behalf of Edwards Lifesciences Corporation and its subsidiaries.

*No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients. Additional clinical data for up to 10 years of follow-up are being collected to monitor the long-term safety and performance of RESILIA tissue.