Device Dossier

Masters Series Mitral Mechanical Heart Valve Poly HP Sewing Cuff - Mitral bi-leaflet mechanical heart valve prosthesis

Device Dossier for Masters Series Mitral Mechanical Heart Valve Poly HP Sewing Cuff - Mitral bi-leaflet mechanical heart valve prosthesis (Mitral…

Intended purpose

The Masters Series Mitral Mechanical Heart Valve Poly HP Sewing Cuff is intended to replace native mitral heart valves or previously implanted mitral prosthetic valves. The valve is indicated for use as a replacement valve in patients with a diseased, damaged, or malfunctioning mitral heart valve or as a replacement for a prosthetic heart valve.

Functional description

The valves are rotatable, bi-leaflet replacement heart valves manufactured from pyrolytic carbon designed for implantation in the mitral position. The valve is designed for supra-annular cuff placement and includes a metallic ring assembly within the sewing cuff that allows the valve to be rotated in-situ.

TGA Public Summary