Device Dossier

Epic Supra Valve Model ESP100 - Aortic heart valve bioprosthesis

Device Dossier for Epic Supra Valve Model ESP100 - Aortic heart valve bioprosthesis (Aortic heart valve bioprosthesis, Class III, sponsor Abbott…

Intended purpose

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

Functional description

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

TGA Public Summary