Device Dossier

Regent Mechanical Heart Valve - Aortic bi-leaflet mechanical heart valve prosthesis

Device Dossier for Regent Mechanical Heart Valve - Aortic bi-leaflet mechanical heart valve prosthesis (Aortic bi-leaflet mechanical heart valve…

Intended purpose

The Regent Mechanical Heart Valve is intended to replace native aortic heart valves or previously implanted aortic prosthetic valves. It is indicated for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic heart valve or as a replacement for a prosthetic heart valve.

Functional description

The Regent™ Mechanical Heart Valve is a bileaflet valve, designed for supra-annular implantation in the aortic position. After suturing, the valve may be rotated to the surgeon's preferred in situ position. The rotation mechanism within the valve sewing cuff is radiopaque. The valve is supplied on a valve holder/rotator and packaged with a disposable plastic collar that supports and protects the valve during shipment and storage. The valve is supplied sterile.

TGA Public Summary