Device Dossier

Novosyn - Suture, polyglactin

Device Dossier for Novosyn - Suture, polyglactin (Suture, polyglactin, Class III, sponsor B Braun). ARTG record, intended purpose, GMDN category —…

Intended purpose

Novosyn® is indicated for for general soft tissue approximation and /or ligation in all surgical specialities and in applications where surgical practice requires the use of synthetic, absorbable, braided suture materials, particularly in the region of the gastro-intestinal tract, in gynaecology and urology and ligatures. Novosyn® is also indicated for ophthalmology (e.g. strabismus operation) and for microsurgery (e.g. peripheral nerve anastomosis and still growing tissues) if an absorbable suture material is preferred.

Functional description

Novosyn®, the new PGLA suture generation consists of braided Poly(glycolide-co-L-lactid 90/10) filaments. Novosyn® is metabolized to glycolic acid and lactic acid by hydrolysis without causing any enduring change in the region of the wound. About 75% of the original tensile strength remains after 14 days of implantation, about 40-50% after 21 days and about 25% after 28 days. The complete mass absorption of Novosyn® takes place at 56-70 days, when the tissue is normally perfused.’

TGA Public Summary