Sofregen - Model SERI - Surgical Biomedical Silk Scaffold
SERI® Surgical Scaffold was cleared for use in the U.S. in April of 2013. SERI® provides predictable tissue regeneration, transferring load-bearing responsibility within 12 months. SERI® Surgical Scaffold is indicated for use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction.
- Patients with a known allergy to silk
- Contraindicated for direct contact with bowel or viscera where formation of adhesions may occur
- SERI® Surgical Scaffold must be placed in maximum possible contact with healthy well-vascularized tissue to encourage ingrowth and tissue remodeling
- Caution should be used when implanting SERI® Surgical Scaffold in pregnant women. The use of a device that can impede tissue expansion may be hazardous during pregnancy
Adverse reactions are those typically associated with surgically implantable materials, including infection, inflammation, adhesion formation, fistula formation, and extrusion.
Before using SERI® Surgical Scaffold, read the Instructions for Use which accompany the product for full safety information. This can be found here.