Meet SERI® Surgical Scaffold

The first and only Silk-derived Biological Scaffold is here

When it comes to soft tissue support and repair products, SERI® Surgical Scaffold is different. Unlike other products that are derived from human cadaver or animal tissue, SERI® Surgical Scaffold is an ultra pure, sterile, silk-derived bioprotein.2

What makes SERI® Surgical Scaffold different

Through bioreplacement, SERI® Surgical Scaffold facilitates the generation of native, well-vascularized tissue that is ≈ twice the starting thickness of the scaffold alone at 24 months.1,*

In addition, SERI® Surgical Scaffold offers the following characteristics:

  • Facilitates neovascularization (as early as 2 days) and native tissue generation over time1,*
  • Native tissue provides lasting support and strength through 24 months1,*
  • At 24 months, native tissue demonstrated nearly twice the average strength of ovine fascia1,*
  • Showed favorable integration and predictable bioresorption over time1,*
  • Demonstrated substantial bioreplacement through 24 months1,*

*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.

SERI® Surgical Scaffold is cleared for use in abdominal wall procedures requiring soft tissue support and repair.2

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

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Support and Strength From Native Tissue1,*

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Bioreplaced
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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