Device Dossier
Sofsilk Wax Coated Braided Silk - Suture, silk
Device Dossier for Sofsilk Wax Coated Braided Silk - Suture, silk (Silk suture, sterile, Class III, sponsor Medtronic). ARTG record, intended purpose,…
- GMDN category: Silk suture, sterile
Intended purpose
Sofsilk™ sutures are indicated for use in soft tissue approximation and/or ligation.
Functional description
Sofsilk™ sutures elicit a minimal acute inflammatory reaction in tissue, which is followed by gradual encapsulation of the suture by fibrous connective tissue. Sofsilk™ sutures undergo progressive degradation of the proteinaceous silk fiber in vivo which results in gradual loss of the suture’s tensile strength over time.