Edwards’ Mitris Resilia Mitral Valve Gains EU Nod

Edwards Lifesciences has earned EU approval for its Mitris Resilia tissue valve replacement designed for the heart’s mitral position.
 
Mitris Resilia is made of bovine pericardial tissue, which the company said reduces calcium buildup on the valve. It has a saddle-shaped sewing cuff that mimics the native mitral valve’s asymmetric shape. Based on the Edwards PeriMount valve design with a nitinol wireform, Mitris Resilia is visible under fluoroscopy.
 
COMMENCE aortic trial data on Resilia tissue showed 99.3% freedom from structural valve deterioration and 97.2% freedom from reoperation through seven years. The trial also showed 98.7% freedom from structural valve deterioration at five years.
 
Resilia anti-calcification technology lets the valves be stored under dry packaging conditions, according to Edwards.
 
“Edwards Lifesciences is committed to addressing the needs of patients with structural heart disease,” Edwards senior VP of Surgical in Europe John Barry told the press. “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 gained U.S. Food and Drug Administration (FDA) approval in 2022.
 
“Mitral valve disease is prevalent and patients experience the disease in various ways. For patients who need mitral valve replacement, the advanced MITRIS RESILIA valve, designed to mimic the native valve, is based on a trusted pericardial PERIMOUNT,” said Dr. Daniel Pereda Arnau, Head of Section, Cardiac Surgery Department, H. Clínic de Barcelona. “As valve durability is becoming increasingly important, the integrity-preservation technology incorporated in the RESILIA tissue that will potentially allow the valve to last longer, is critical.”