Device Dossier

Epic Valve Mitral Model E100 - Mitral heart valve bioprosthesis

Device Dossier for Epic Valve Mitral Model E100 - Mitral heart valve bioprosthesis (Mitral heart valve bioprosthesis, Class III, sponsor Abbott Medical).…

Intended purpose

The SJM Epic Mitral Valve is intended as a replacement for a diseased, damaged or malformed mitral native heart valve. It may also be used as a replacement for a previously implanted mitral prosthetic heart valve.

Functional description

The SJM Epic Mitral Valve is a triple-composite bioprosthetic heart valve manufactured from select porcine aortic valve cusps.

TGA Public Summary