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…

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.

TGA Public Summary