Device Dossier

Masters Series Mitral Mechanical Heart Valve Poly HP Sewing Cuff Model 15 MHPJ-505 - Mitral bi-leaflet mechanical heart valve prosthesis

Device Dossier for Masters Series Mitral Mechanical Heart Valve Poly HP Sewing Cuff Model 15 MHPJ-505 - Mitral bi-leaflet mechanical heart valve…

Intended purpose

The Masters Series Mitral Mechanical Heart Valve Poly HP Sewing Cuff Model 15MHPJ-505 is intended to replace native mitral heart valves or previously implanted 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 mitral prosthetic heart valve. The target patient population for these valves is pediatric patients with a diseased, damaged, or malfunctioning mitral 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