Device Dossier

Masters Series Aortic Mechanical Heart Valves with Hemodynamic Plus (HP) Sewing Cuff - Aortic bi-leaflet mechanical heart valve prosthesis

Device Dossier for Masters Series Aortic Mechanical Heart Valves with Hemodynamic Plus (HP) Sewing Cuff - Aortic bi-leaflet mechanical heart valve…

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 Masters Hemodynamic Plus (HP) valve models are designed to maximise effective orifice area and for supra-annular cuff placement.

TGA Public Summary