News of the latest regulatory milestone follows the receipt of CE mark approval for the Evoque valve system last week. Edwards also reported positive TAVR data at TCT 2023 and recorded third-quarter sales growth in its latest earnings report.
The company designed this valve, made with bovine pericardial tissue technology, specifically for the heart’s mitral position. Bovine tissue technology reduces calcium build-up on the valve, preserving and protecting the tissue. It allows the valve to potentially last longer than conventional bioprosthetic valves.
Mitris Resilia features a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve. Edwards based its low-profile valve on the Perimount design with a nitinol wireform to fold inward during implantation. The valve is visible under fluoroscopy to facilitate future transcatheter interventions for patients.
Edwards said recent data on its Resilia tissue demonstrated low rates of structural valve deterioration (99.3% freedom from it). It also showed freedom from reoperation (97.2%) through seven years. The company received FDA approval for Mitris Resilia in March 2022.
“Edwards Lifesciences is committed to addressing the needs of patients with structural heart disease,” said John Barry, Edwards’ SVP of Surgical in Europe. “Our Resilia tissue technology is designed for enhanced durability, supporting improved quality of life for patients and relieving the burden on healthcare systems.”
The introduction of a new device in Europe comes at an interesting time as Edwards also faces antitrust scrutiny on the continent. A report earlier this month said European officials probed Edwards Lifesciences over potential antitrust activity because of patent practices.
