1. Data on file, Sofregen, Inc. 2. SERI® Surgical Scaffold. Instructions for Use, 2013. 3. Shimizu M. Structural basis of silk fibre. In: Hojo N, ed. Structure of Silk Yarn. Part A: Biological and Physical Aspects. Enfield, NH: Science Publishers, Inc.; 2000:7-17. 4. Altman GH, Horan RL, Lu HH, et al. Silk matrix for tissue engineered anterior cruciate ligaments. Biomaterials. 2002;23:4131-4141. 5. Leknes KN, Roynstrand IT, Selvig KA. Human gingival tissue reactions to silk and expanded polytetrafluoroethylene sutures. J Periodontol. 2005;76(1):34-42. 6. Stedman’s Medical Dictionary. 28th ed. Lippincott Williams & Wilkins. 2006. 7. Menon NG, Rodriguez ED, Byrnes CK, Girotto JA, Goldberg NH, Silverman RP. Revascularization of human acellular dermis in full-thickness abdominal wall reconstruction in the rabbit model. Ann Plast Surg. 2003;50(5):523-527. 8. Pittman RN. Regulation of Tissue Oxygenation. San Rafael, CA: Morgan & Claypool Life Sciences; 2011:1-14. 9. Altman GH, Diaz F, Jakuba C, et al. Silk-based biomaterials. Biomaterials. 2003;24(3):401-416.

*Methodology: In an ovine subcutaneous thoracic wall implant study designed to measure the strength and thickness of SERI® Surgical Scaffold and newly generated native tissue at up to 24 months after implantation of SERI®.1
Note: Similar studies in humans have not been performed.

Methodology: In a study using SERI® Surgical Scaffold in a rat model of abdominal wall defect.1
Note: Similar studies in humans have not been performed.


Indications for Use
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.

Important Safety Information
Contraindications

  • Patients with a known allergy to silk
  • Contraindicated for direct contact with bowel or viscera where formation of adhesions may occur

Warnings

  • 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
Adverse reactions are those typically associated with surgically implantable materials, including infection, inflammation, adhesion formation, fistula formation, and extrusion.

Important: Before using SERI® Surgical Scaffold, read the Instructions for Use which accompany the product for full safety information. This can be found here.

Caution: Rx only.

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