Device Dossier

Biodesign Rectopexy Graft - Multi-purpose surgical mesh, collagen

Device Dossier for Biodesign Rectopexy Graft - Multi-purpose surgical mesh, collagen (Multi-purpose surgical mesh, collagen, Class III, sponsor…

Intended purpose

The Biodesign Rectopexy Graft is intended to support / reinforce soft tissue in surgical procedures for open and laparoscopic repair of rectal prolapse / rectal intussusception. This device is not intended tp be used via a transvaginal approach. The device is supplied sterile and intended for one time use.

Functional description

The Biodesign Rectopexy Graft is a dried multi-layered small intestinal submucosa (SIS) sheet used to reinforce soft tissue for the repair of rectal prolapse and rectal intussusception. The graft can be cut to size to accommodate a patient's anatomy. The device requires rehydration in saline of lactated Ringer's solution prior to application. Once in position, the graft is sutured into place.

TGA Public Summary