Device Dossier

Masters Series Aortic Mechanical Heart Valves with Expanded Polyster Sewing Cuff - Aortic bi-leaflet mechanical heart valve prosthesis

Device Dossier for Masters Series Aortic Mechanical Heart Valves with Expanded Polyster Sewing Cuff - Aortic bi-leaflet mechanical heart valve prosthesis…

Intended purpose

To replace native aortic heart valves or previously implanted aortic prosthetic valves.

Functional description

The valves are rotable, bi-leaflet replacement heart valves for implantation in aortic position. The valves are designed for intra-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