Device Dossier
Q-close Mono - Suture, poliglecaprone
Device Dossier for Q-close Mono - Suture, poliglecaprone (Suture, poliglecaprone, Class III, sponsor Revolution Surgical). ARTG record, intended purpose,…
- GMDN category: Suture, poliglecaprone
Intended purpose
Q-close Mono suture is intended for use in general soft tissue approximation and/or ligation where an absorbable suture material is indicated. The safety and effectiveness of Q-close Mono suture has not been established in cardiovascular tissue, neurological tissue, microsurgery and ophthalmic surgery.
Functional description
Q-close Mono suture after implantation elicits a minimal initial inflammatory reaction in tissues and is eventually replaced with an ingrowth of fibrous connective tissue. Q-close Mono suture being absorbable in nature gets absorbed in the tissues by means of hydrolysis, during which the Poliglecaprone-25 polymer is degraded into monomers of adipic acid which is eventually absorbed and metabolized in the body.