Device Dossier
Medtronic Open Pivot heart valve, Model 500FA
Device Dossier for Medtronic Open Pivot heart valve, Model 500FA (Aortic bi-leaflet mechanical heart valve prosthesis, Class III, sponsor Medtronic).…
- GMDN category: Aortic bi-leaflet mechanical heart valve prosthesis
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.