SERI® Surgical Scaffold facilitates native tissue generation over time1

As seen in a full-scale animal model study, SERI® Surgical Scaffold and newly generated tissue demonstrated thickness at 3 months.1 In the same study, native tissue contributed approximately twice the starting thickness of the scaffold alone at 24 months.1 At this point, most of SERI® Surgical Scaffold has been bioreplaced with native, well-vascularized tissue—meaning the resulting thickness comes almost entirely from the newly generated tissue.1

Native tissue generation with SERI® Surgical Scaffold1


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.


Bioreplaced
Over Time1,*

Learn More

SURGEON
EXPERIENCE

Sign Up For Exclusive Features

Support and Strength From Native Tissue1,*

Learn More®

*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.

Instructions for Use   |   Sofregen Medical Privacy Statement   |  

Terms of Use   |   SofregenMedical.com   |   Contact Sofregen Medical   |  

Site Map   |   References

©Sofregen Medical Inc., One Kendall Square, Cambridge, MA 02139 ® marks owned by Sofregen Medical Ireland LTD
  APC12MN15   152333