Device Dossier
INSPIRIS RESILIA Aortic Valve - Aortic heart valve bioprosthesis
Device Dossier for INSPIRIS RESILIA Aortic Valve - Aortic heart valve bioprosthesis (Aortic heart valve bioprosthesis, Class III, sponsor Edwards…
- GMDN category: Aortic heart valve bioprosthesis
Intended purpose
The INSPIRIS RESILIA aortic valve is intended for use as a heart valve replacement.
Functional description
The INSPIRIS RESILIA aortic valve, Model 11500A is a stented trileaflet valve comprised of RESILIA bovine pericardial tissue that is mounted on a flexible frame. The valve is stored under dry packaging conditions and consequently does not require rinsing prior to implantation.