SERI® Surgical Scaffold is bioreplaced over time1

SERI® Surgical Scaffold through 24 months1,*

Collagenase-processed SERI® Surgical Scaffold microscopy images.



Predictable bioresorption through cellular digestion as native, vascularized tissue is generated in its place1,2

Delivers continuous soft tissue support through gradual bioreplacement1,2

SERI® Surgical Scaffold + Tissue: 1-month histology1,*

Notice the tissue integration beginning to take place.1

SERI® Surgical Scaffold + Tissue: 12-month histology1,*

Neovascularization is marked by the proliferation of new blood vessels.1 When comparing photos, there is less pink (SERI® Surgical Scaffold) and more blue (collagen) as time goes on.1


Integration begins as early as 2 days1,†

The tissue response to SERI® Surgical Scaffold demonstrates integration and neovascularization as the scaffold is bioreplaced over time with collagen.1

*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.

Favorable
Biocompatibility1,*
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Support and Strength
from Native Tissue1,*
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techniques using SERI®

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.

*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.


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