Device Dossier

FILAXYN™ - Suture, polydioxanone

Device Dossier for FILAXYN™ - Suture, polydioxanone (Suture, polydioxanone, Class III, sponsor Meril). ARTG record, intended purpose, GMDN category —…

Intended purpose

Intended for use in general soft tissue approximation including use in pediatric cardiovascular tissue, microsurgery and ophthalmic surgery. These sutures are particularly useful where an absorbable suture with prolonged wound support (up to 42 days) is required.

Functional description

Sterile, synthetic absorbable monofilament suture composed of Poly (p-dioxanone) attached to standard stainless steel needles. Leads to ingrowth of fibrous connective tissue due to minimal initial inflammatory tissue reaction. It gradually loses tensile strength and is finally absorbed by hydrolytic process. 70% tensile strength retained until 14 days, 50%-60% retained until 28 days. Complete absorption usually takes place between 180-220 days.

TGA Public Summary