Device Dossier

Medtronic Open Pivot heart valve, Model 505DA - Prosthesis, internal, valve, cardiac, artificial

Device Dossier for Medtronic Open Pivot heart valve, Model 505DA - Prosthesis, internal, valve, cardiac, artificial (Aortic bi-leaflet mechanical heart…

Intended purpose

The intended purpose of the Medtronic Open Pivot heart valve is to restore unidirectional blood flow through the aortic and/or mitral annulus by replacing a diseased or damaged heart valve.

Functional description

The device operates similarly to native aortic and mitral valves, thereby preventing backflow of blood. Normal cardiac valves offer little resistance to the flow of blood caused by the changing pressure across their surfaces. Mechanical valves behave similarly, responding to the pressure and flow of blood through the chambers. Once implanted, the design allows valve leaflets to respond passively to hemodynamic stimuli manifested as pressure gradients and flow changes within the heart.

TGA Public Summary