Device Dossier

MONOFAST - Suture, polydioxanone

Device Dossier for MONOFAST - Suture, polydioxanone (Suture, polydioxanone, Class III, sponsor Geistlich Pharma). ARTG record, intended purpose, GMDN…

Intended purpose

MONOFAST monofilament synthetic absorbable suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular tissues and tissues of central nervous system and also in microsurgery and ophthalmic surgery.

Functional description

Synthetic absorbable monofilament sterile surgical suture composed from a copolymer of polyglycolic acid-co-polycaprolactone. Elicits a minimal inflammatory reaction, which is followed by the development of fibrous connective tissue in place. Retention of the suture is 68-78% of the original tensile strength after 1"' week & approximately 30% after the 2nd week. Absorption of the suture is completed after a period of 90 -110 days. Original tensile strength is lost 28 days after implantation.

TGA Public Summary