Device Dossier

Avalus Ultra Bioprosthesis - Aortic heart valve bioprosthesis

Device Dossier for Avalus Ultra Bioprosthesis - Aortic heart valve bioprosthesis (Aortic heart valve bioprosthesis, Class III, sponsor Medtronic). ARTG…

Intended purpose

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

Functional description

The Avalus Ultra bioprosthesis is indicated for the replacement of pathologic or prosthetic aortic valves. 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