Device Dossier
Perceval S Sutureless Aortic heart Valve - Aortic heart valve bioprosthesis
Device Dossier for Perceval S Sutureless Aortic heart Valve - Aortic heart valve bioprosthesis (Aortic heart valve bioprosthesis, Class III, sponsor BTC…
- GMDN category: Aortic heart valve bioprosthesis
Intended purpose
Perceval S prosthesis is indicated for the replacement of a diseased native or a malfunctioning prosthetic aortic valve via open heart surgery. The Prosthesis is indicated in patients who meet the following criteria: -Subjects of age greater or equal to 65 years -Subjects with aortic valve stenosis or steno-insufficiency
Functional description
Perceval S is a bioprosthetic valve designed to replace a diseased native or a malfunctioning prosthetic aortic valve via open heart surgery, with the unique characteristic of allowing sutureless positioning and anchoring at the implant site. Perceval S prosthesis consists of a tissue component made from bovine pericardium and a self-expandable Nitinol stent, which has the dual role of supporting the valve and fixing it in place.