For US Residents

The latest advance in dural regeneration matrix technology.

Suturable DuraGen,™ Integra’s next-generation Dural Regeneration Matrix, is specially designed to meet all your cranial and spinal duraplasty needs.¹ The stronger integrated-matrix design combines suturability with the proven performance of our DuraGen Plus® onlay.

Suturable DuraGen. For demanding procedures.

Continuous innovation with proven safety and effectiveness in over 475,000 patients ²

• Proven effectiveness against CSF leakage,^3-6 now suturable for even greater security and protection
• Minimal potential for adhesion formation only following significant disruption of the Pia-arachnoid with no reported foreign body reactions or immune rejection^3-6
• 30 years of innovative application in tissue regeneration technology
• Integra’s Ultra Pure Collagen technology is the foundation of products used by neuro, plastic and reconstructive, orthopedic and oral surgeons worldwide
• Integra’s Ultra Pure Collagen technology has been used in over 10 million procedures
  

Suturable DuraGen. The strength to perform under pressure.

• Excellent suture retention while maintaining the biological activity of DuraGen Plus
• Designed for repairing dural defects where mechanical anchoring of the graft is preferred.
• Fully resorbed and replaced by native tissue with complete dural closure²
• No reported encapsulation^2-6

Part Numbers: DURS1391, DURS2291, DURS3391, DURS4591.

References
1. Suturable DuraGen™ Instructions for Use, Integra LifeSciences™ Corporation; 2006.
2. Data on file, Integra LifeSciences Corporation.
3. P. Narotam, A. Gousseau, G. McGinn. Collagen Matrix (DuraGen) for duraplasty following cranial and spinal surgery. 35th Canadian Congress of Neurological Sciences, Ottawa, Canada, June 2000.
4. P. Narotam, S. José, N. Nathoo, C. Taylor, Y. Vora. Collagen Matrix (DuraGen®) in Spinal Durotomy: Technique Appraisal and Clinical Results. 18th Annual Meeting of the North American Spine Society, San Diego, California, October 2003.
5. G. Heuer, M. Stiefel, E. Maloney-Wilensky, S. Danish, C. Dolinskas, P. LeRoux. DuraGen is an Effective Dural Substitute: Clinical Experience with 100 Cases. American Association of Neurological Surgeons Annual Meeting, April 2003.
6. P. Narotam, S. José, N. Nathoo, C. Taylor, Y. Vora. Collagen Matrix (DuraGen) in Dural Repair: Analysis of a New Modified Technique. SPINE 29:2861-2867, December 2004.

Adverse Events
Possible complications can occur with any neurosurgical procedure and include cerebrospinal fluid leaks, infection, delayed hemorrhage and adhesion formation. In clinical evaluations involving 1,096 patients, postoperative wound infection rates for Integra's collagen matrix were reported at approximately the same rate as the control group. Postoperative cerebrospinal fluid leaks were reported in 3 of 67 patients who underwent intradural posterior fossa procedures. Macroscopic evaluations revealed minimal adhesion formation only when there was significant disruption of the pia-arachnoid. There were no reports of graft encapsulation, neomembrane formation or foreign body reactions. There were no reports of graft rejections at histology.¹
*The collagen used to manufacture Suturable DuraGen is currently used in the manufacture of artificial skin, absorbable hemostatic sponges and absorbable wound dressings. The manufacturing process for Suturable DuraGen meets US and European standards for animal tissue sourcing, handling and inactivation of spongiform encephalopathy (SE) pathogens. This process involves a treatment with sodium hydroxide that is a recognized method of inactivation of SE pathogens.^1,2