Suturable DuraGen™


Catalog excerpts

Suturable DuraGen™ - 1

From the leader in regenerative technology Suturable DuraGen™ Dural Regeneration Matrix Ordering Information 4 Catalog Number Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 Customer Service: 800-997-4868 (USA and Canada) 800-654-2873 (USA and Canada) 609-275-0500 (Outside USA) 609-275-5363 (Fax) Sizes shown in inches at actual size. 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 rejection at histology. 1 The Ultra Pure Collagen™ Technology 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 DuraGen, DuraGen Plus, NeuraGen are registered trademarks of Integra LifeSciences Corporation. Suturable DuraGen, Endura, NeuraWrap, Ultra Pure Collagen, Integra and the Integra wave logo are trademarks of Integra LifeSciences Corporation. DuraGen, DuraGen Plus, and Suturable DuraGen are covered by U.S. Patent No. 5,997,895. © 2006 Integra LifeSciences Corporation. All Rights Reserved. Printed in U.S.A. NS792-06/06 References: 1. Suturable DuraGen™ Instructions for Use, Integra LifeSciences™ Corporation; 2003. 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.

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Suturable DuraGen™ - 2

DURAL REGENERATION MATRIX From the leader in regenerative technology The strength to suture with the performance of an onlay. Integra"

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Suturable DuraGen™ - 3

Suturable DuraGen Matrix The integrated solution The latest advance in dural regeneration matrix technology. Suturable DuraGen matrix has two integrated components: an onlay matrix component (bottom) and an enhanced strength component (top). The textured surface of the enhanced strength component consists of a long collagen fiber network that imparts strength and promotes cellular ingrowth. Pre-Clinical Study Histology T=12d Suturable DuraGen, Integra’s next-generation Dural Regeneration Matrix, is specially designed to meet all your cranial and spinal duraplasty needs.1 The stronger...

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Suturable DuraGen™ - 4

Continuous innovation with proven safety and effectiveness in over 450,000 patients. 2 • Proven effectiveness against CSF leakage,3-6 now suturable for even greater security and protection • Minimal potential for adhesion formation with no reported foreign body reactions or immune rejection3-6 • 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 successfully in...

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