Device Dossier

SJM Masters Valve Rotatable Mechanical Mitral Valve Standard Series, Expanded Polyester Cuff Model MECJ-502

Device Dossier for SJM Masters Valve Rotatable Mechanical Mitral Valve Standard Series, Expanded Polyester Cuff Model MECJ-502 (Prosthesis, internal,…

Intended purpose

Intended for use as a replacement valve in patients with a diseased, damaged or malfunctioning mitral heart valve. This device may also be used to replace a previously implanted prosthetic heart valve

Functional description

A radiopaque mechanism within the sewing cuff allows the valve orifice ring to be rotated to the preferred in situ position. The supra-annular sewing cuff has four markers which are used as reference points for the valve’s orientation or the placement of sutures. The cuff is made from double velour knitted polyester fibre which allows for rapid, controlled, endothelial in-growth over the entire cuff. The expanded cuff has 10% more cuff material in the mitral configuration.

TGA Public Summary