Device Dossier

Mosaic Pocine Bioprosthesis Model 305 - Aortic heart valve bioprosthesis

Device Dossier for Mosaic Pocine Bioprosthesis Model 305 - Aortic heart valve bioprosthesis (Aortic heart valve bioprosthesis, Class III, sponsor…

Intended purpose

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

Functional description

The device operates similarly to the native mitral valve, thereby preventing backflow of blood. 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. 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