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Edwards Achieves CE Mark for MITRIS RESILIA Valve, Advancing Mitral Replacement Surgery

Friday, October 27, 2023

Edwards Lifesciences has made a significant announcement, as they've recently obtained the CE Mark for their innovative MITRIS RESILIA valve, a specialized tissue valve designed for the unique demands of the mitral position within the heart. What sets this valve apart is the use of advanced technology in constructing it from bovine pericardial tissue, which effectively minimizes the formation of calcium deposits on the valve. This breakthrough not only preserves the tissue but also extends the potential longevity of the valve, surpassing traditional bioprosthetic valves.*

The MITRIS RESILIA valve is distinctively equipped with a saddle-shaped sewing cuff, replicating the asymmetrical shape of the native mitral valve. Built upon the successful Edwards PERIMOUNT valve design, it includes a Nitinol wire that enables it to fold inward smoothly during the implantation process. Additionally, the valve is visible under fluoroscopy, presenting the possibility of future transcatheter procedures for patients.

Promising results from the COMMENCE aortic trial involving RESILIA tissue reveal its effectiveness, with low rates of structural valve deterioration (an impressive 99.3% freedom from such deterioration), consistently stable gradients, and a high degree of freedom from reoperation (97.2%) over seven years.

Furthermore, findings from the COMMENCE mitral study show stable hemodynamics and no signs of valve structure deterioration (98.7%) over a five-year period. An added advantage is the anti-limescale technology incorporated into RESILIA, which allows for convenient storage in dry packaging conditions. 

Source: businesswire.com

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