Device Dossier

Q-close PD Synth - Suture, polydioxanone

Device Dossier for Q-close PD Synth - Suture, polydioxanone (Suture, polydioxanone, Class III, sponsor Revolution Surgical). ARTG record, intended…

Intended purpose

Q-close PD Synth suture is intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. The safety and effectiveness of Q-close PD Synth suture has not been established in neurological tissue, adult cardiovascular tissue and microsurgery.

Functional description

After implantation, Q-close PD Synth suture elicits a minimal initial inflammatory reaction in tissues and is eventually replaced with an ingrowth of fibrous connective tissue. This suture being absorbable in nature gets absorbed in the tissues by means of hydrolysis, during which the Polydioxanone polymer is degraded into monomers of 2-hydroxyethoxyacetic acid which is eventually absorbed and metabolized in the body.

TGA Public Summary