Device Dossier

Epic ™ Plus Holder Handle (Aortic) - Heart valve prosthesis sizer handle

Device Dossier for Epic ™ Plus Holder Handle (Aortic) - Heart valve prosthesis sizer handle (Heart valve prosthesis sizer handle, Class III, sponsor…

Intended purpose

The Holder Handle is intended to facilitate valve handling during the tissue heart valve implant procedure.

Functional description

A hand-held manual surgical instrument intended to be used during cardiac valve repair or replacement as a handle to which an interchangeable valve sizer is attached to allow the surgeon to evaluate the valve opening (patient annulus) into which the appropriate sized annuloplasty ring or replacement valve will be implanted.

TGA Public Summary