Device Dossier

Perceval PLUS sutureless aortic heart valve - Aortic heart valve bioprosthesis

Device Dossier for Perceval PLUS sutureless aortic heart valve - Aortic heart valve bioprosthesis (Aortic heart valve bioprosthesis, Class III, sponsor…

Intended purpose

PERCEVAL PLUS prosthesis is intended to replace a damaged native aortic heart valve or a malfunctioning aortic prosthesis via open heart surgery. It is is indicated for use in adult patients: - suffering from aortic valve stenosis or steno-insufficiency; - with a previously implanted aortic valve prosthesis that is no longer functioning adequately and requires replacement

Functional description

PERCEVAL PLUS is a bioprosthetic valve with the unique characteristic of allowing sutureless positioning and anchoring at the implant site. Prior to implantation the prosthesis diameter is reduced to a suitable size for loading it on the holder. The valve is then positioned and released in the aortic root, where the stent design and its ability to apply a radial force to the annulus allows stable anchoring of the device

TGA Public Summary