Device Dossier

Epic ™ Max Stented Tissue Valves - Aortic heart valve bioprosthesis

Device Dossier for Epic ™ Max Stented Tissue Valves - Aortic heart valve bioprosthesis (Aortic heart valve bioprosthesis, Class III, sponsor Abbott…

Intended purpose

The Epic™ Max Valve is intended to replace native aortic heart valves or previously implanted aortic prosthetic valves.

Functional description

The Epic Max valves are bioprosthetic heart valves manufactured from select porcine aortic valve cusps intended to replace native mitral or aortic heart valves or previously implanted aortic or mitral prosthetic valves.

TGA Public Summary