Device Dossier

Vicryl™ (Polyglactin 910) Endoloop ™ 45cm - Suture, polyglactin

Device Dossier for Vicryl™ (Polyglactin 910) Endoloop ™ 45cm - Suture, polyglactin (Suture, polyglactin, Class III, sponsor Johnson & Johnson Medical).…

Intended purpose

VICRYL sutures are intended for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, peripheral nerve anastomosis and microsurgery for vessels less than 2mm diameter. The Endoloop ligature is for use in endoscopic suturing and knot tying. It can be used in any type of endoscopic procedure using sutures or ligatures and enable extracorporeal and intracorporeal knots to be tied.

Functional description

Endoloop, a single-use medical device for endoscopic procedures, includes a plastic tube (Nylon 12, length 30.5cm) that is narrowed on one end and scored on the other. A suture length is formed into a ligature loop with a knot, becoming secure when the device is activated. The opposite end of the suture is fastened to the scored end, which acts as a handle. The VICRYL (Polyglactin 910) suture is a synthetic, absorbable sterile suture composed of a copolymer of 90% glycolide and 10% L-lactide.

TGA Public Summary