Device Dossier

Model 995 - Aortic heart valve bioprosthesis

Device Dossier for Model 995 - Aortic heart valve bioprosthesis (Aortic heart valve bioprosthesis, Class III, sponsor Medtronic). ARTG record, intended…

Intended purpose

The intended purpose of the Freestyle bioprosthesis is to restore unidirectional blood flow through the aortic or pulmonary annulus by replacing a diseased or damaged heart valve in the aortic or pulmonary position.

Functional description

Normal cardiac valves offer little resistance to the flow of blood caused by the changing pressure across their surfaces. Bioprosthetic valves behave in a similar manner responding to the pressure and flow of blood through the chambers. Therefore, valve motion is passive and is the sole result of transvalvular pressure gradients and flow without the contribution of contraction and distention of the surrounding structure.

TGA Public Summary