Device Dossier
MITRIS RESILIA Mitral Valve - Mitral heart valve bioprosthesis
Device Dossier for MITRIS RESILIA Mitral Valve - Mitral heart valve bioprosthesis (Mitral heart valve bioprosthesis, Class III, sponsor Edwards…
- GMDN category: Mitral heart valve bioprosthesis
Intended purpose
Intended for use as a heart valve replacement. The device is indicated for patients who require replacement of their native or prosthetic mitral valve.
Functional description
The MITRIS RESILIA mitral valve is a stented tri-leaflet prosthetic heart valve comprised of RESILIA bovine pericardial tissue. This low-profile valve is based on the Edwards PERIMOUNT valve design with a nitinol wire form. The valve is mounted on a retainer with a holder system attached to the valve.