Not your ordinary silk

Silk-derived biological SERI® Surgical Scaffold exhibits favorable biocompatibility with minimal inflammation1

All silks are not created equally. Ultra pure SERI® Surgical Scaffold is different from ordinary surgical silk.1,4,5

Ordinary silk sutures contain sericin, which is associated with an exaggerated inflammatory response.1,5

Only SERI® Surgical Scaffold undergoes a proprietary purified bioengineering process designed to remove sericin and other impurities for an ultra pure, sterile product.2


Ordinary silk sutures contain sericin, which is associated with an exaggerated inflammatory response.1,5

Commercial silk sutures: Encapsulation1

Raw silk fiber with its natural sericin coating and impurities3,4

  • The components in silk sutures can cause excessive inflammation5
    Commercial silk suture is made of fibrous proteins that are first processed into strands, then braided, and may be dyed and coated with wax or silicone.5 These silk sutures typically can become encapsulated and do not integrate into the native tissue.1

Only SERI® Surgical Scaffold undergoes a proprietary purified bioengineering process designed to remove sericin and other impurities for an ultra pure, sterile product.2

SERI® Surgical Scaffold + Tissue: Favorably integrates within the tissue1

Ultra pure, silk-derived fibroin after removal of the sericin encasement and other impurities4

  • Ultra pure SERI® Surgical Scaffold demonstrates favorable integration and predictable bioresorption1
    Tissue response to SERI® Surgical Scaffold exhibits minimal inflammation that is confined to the silk-derived scaffold. This helps promote favorable integration and neovascularization as the scaffold is bioreplaced over time with collagen.1

Methodology: In a rat abdominal wall model study of cell and tissue response to intramuscular implantation of SERI® Surgical Scaffold fibers and Sofsilk® nonresorbable silk sutures 28 days after implantation using histology.1
Note: Similar studies in humans have not been performed.

Predictable Product Characteristics

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Facilitates Neovascularization (As Early As 2 Days) and Native Tissue Generation Over Time1,*

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*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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