Edwards Lifesciences has obtained a CE Mark for the MITRIS RESILIA valve, a tissue valve replacement designed for the mitral position of the heart.
The valve is produced using bovine pericardial tissue technology to minimise calcium accumulation.
The saddle-shaped sewing cuff of the valve mimics the asymmetrical form of the native mitral valve.
MITRIS RESILIA is a low-profile valve that deploys the Edwards PERIMOUNT valve design and incorporates a nitinol wire form that enables it to fold inward at the time of implantation.
The valve can be seen under fluoroscopy, which enables potential transcatheter interventions for patients in the future.
New findings from the COMMENCE aortic trial showed promising outcomes for the RESILIA tissue, including a 99.3% freedom from structural valve deterioration rate, stable gradients and 97.2% freedom from reoperation over seven years.
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The RESILIA anti-calcification technology also facilitates the storage of devices under dry packaging conditions.
Edwards Surgical Europe senior vice-president John Barry said: “Edwards Lifesciences is committed to addressing the needs of patients with structural heart disease.
“Our RESILIA tissue technology is designed for enhanced durability, supporting improved quality of life for patients and relieving the burden on healthcare systems.”
Last year, the company received approval from the US Food and Drug Administration for the MITRIS RESILIA valve.
In September this year, the Ohio State University Wexner Medical Center in the US randomised the world’s first patient in a clinical trial to assess the effectiveness of Edwards’ device aimed at relieving symptoms of heart failure.
