SERI® Surgical Scaffold Silk: Innovative design. Consistent quality.

SERI® Surgical Scaffold is a knitted scaffold composed of ultra pure, silk-derived fibroin2 sourced from the Bombyx mori silkworm. As such, SERI® Surgical Scaffold is not derived from human cadaver or animal tissue.

How SERI® Surgical Scaffold Silk is manufactured

Raw silk protein filaments are combined by helical twisting to form a multifilament protein fiber.2 These raw silk fibers are composed of fibroin protein core filaments that are naturally coated with the globular protein sericin.3

Raw silk protein filaments are twisted into a multifilament fiber2

The purified bioengineering process removes the sericin, leaving behind fibroin protein filament of ≥ 95% purity on average.1,3,4

Sericin is extracted from the fiber, leaving behind fibroin protein with minimal residual sericin1,4

Purified fibers are then assembled into a 3-dimensional patterned scaffold, with pores that are at least 10,000 µm2.1,2 The resulting scaffold is mechanically strong, flexible, and tear resistant.1,2 Plus, SERI® Surgical Scaffold can be easily cut with surgical scissors and will not unravel or fray.1,2

Fibers are knitted into a patterned scaffold2


Raw silk protein filaments are combined by helical twisting to form a multifilament protein fiber.2 These raw silk fibers are composed of fibroin protein core filaments that are naturally coated with the globular protein sericin.3

The purified bioengineering process removes the sericin, leaving behind fibroin protein filament of ≥ 95% purity on average.1,3,4

Purified fibers are then assembled into a 3-dimensional patterned scaffold, with pores that are at least 10,000 µm2.1,2 The resulting scaffold is mechanically strong, flexible, and tear resistant.1,2 Plus, SERI® Surgical Scaffold can be easily cut with surgical scissors and will not unravel or fray.1,2


Favorable
Biocompatibility1,

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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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