Device Dossier
BIOSYN - Suture, absorbable
Device Dossier for BIOSYN - Suture, absorbable (Suture, polydioxanone, Class III, sponsor Medtronic). ARTG record, intended purpose, GMDN category —…
- GMDN category: Suture, polydioxanone
Intended purpose
BIOSYN synthetic absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery.
Functional description
BIOSYN synthetic absorbable sutures elicit a minimal acute inflammatory reaction in tissues, followed by gradual encapsulation of the suture by fibrous connective tissue. Progressive loss of tensile strength and eventual absorption of Biosyn synthetic absorbable sutures occurs by means of hydrolysis where the suture is broken down to glycolic acid, dioxanoic acid,propane diol and carbon dioxide which are subsequently absorbed and metabolized by the body.