Avalus 400 Bioprosthesis - Aortic heart valve bioprosthesis

Intended purpose

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

Functional description

The device consists of a polyester covered base frame and trileaflet support frame structure shaped to the trileaflet valve. The leaflets are from bovine tissue that have been cross-linked in buffered glutaraldehyde. The leaflets are inserted between the trileaflet support frame and the base frame, and then all components are securely sutured together. A sewing ring is integrated into the inflow base frame cover to allow the user to suture and seat the device in the supra-annular position.