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Dural Regeneration Matrix - Integra lifesciences · 2. Stryker Promotional Material #9410-400-152...

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Integra ® DuraGen ® Dural Regeneration Matrix Limit uncertainty with complete conformability and optimal strength for proven CSF leak prevention.
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Page 1: Dural Regeneration Matrix - Integra lifesciences · 2. Stryker Promotional Material #9410-400-152 Rev. A 3. Collagen Matrix, Inc. Promotional Material #CDSLM Rev. 0 4. Heuer G, Stiefel

Integra® DuraGen®

Dural Regeneration Matrix

Limit uncertainty with complete conformability and optimal strength for proven CSF leak prevention.

Page 2: Dural Regeneration Matrix - Integra lifesciences · 2. Stryker Promotional Material #9410-400-152 Rev. A 3. Collagen Matrix, Inc. Promotional Material #CDSLM Rev. 0 4. Heuer G, Stiefel

* 3 lots and 3 products/lot (n=3 replicates per product) were tested for each product group except DuraMatrix-Onlay membrane. For DuraMatrix-Onlay membrane 3 lots were tested but due to material availability while 9 products were tested from first lot, only one product each was tested from the second lot and the third lot (n=3 replicates/each product).** Data as of January 1, 2012.1. Data on file.

The DuraGen family of products was engineered with the ideal balance of strength and conformability to ensure optimal porosity, sealing, and resorption - leaving the patient with a natural dural repair 1

Integra® DuraGen®

Competitive Comparison

DuraGen graft is an average of 20% more conformable than DuraMatrix-Onlay membrane, ensuring graft approximation at the dural margin to protect against CSF leakage.*C

onfo

rmab

ility

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100

80

60

40

20

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DuraGen Plus Onlay DuraMatrix-Onlay

Clinically Demonstrated CSF Leak Prevention**

Onlay grafts require the graft to intimately conform to and touch the dural margins to close off pathways that could allow CSF flow.

DuraGen graft has a high level of conformability verses DuraMatrix-Onlay membrane, allowing for intimate dural contact without suture. In 1,400 patients within 10 published clinical studies, a CSF leakage rate of 2.1% was observed for DuraGen graft.

DuraMatrix-Onlay™ Membrane

ConformabilityConformability is critical in the prevention of CSF leakage when using an onlay graft. The DuraGen® graft conforms intimately when hydrated to the complex surfaces of the exposed brain or spinal cord, rapidly forming a biological clot that seals to protect against CSF leakage.1

DuraGen Plus Onlay

Optimal Conformability Gaps May Allow CSF Leakage

Gaps May AllowCSF Leakage

DuraMatrix-Onlay™ Membrane

DuraMatrix-Onlay membrane has 20% less conformability than DuraGen grafts. This decreases dural contact and may require suture to achieve direct dural apposition. No clinical data examining CSF leakage rate was found for DuraMatrix-Onlay *. *

Page 3: Dural Regeneration Matrix - Integra lifesciences · 2. Stryker Promotional Material #9410-400-152 Rev. A 3. Collagen Matrix, Inc. Promotional Material #CDSLM Rev. 0 4. Heuer G, Stiefel

2. Stryker Promotional Material #9410-400-152 Rev. A3. Collagen Matrix, Inc. Promotional Material #CDSLM Rev. 04. Heuer G, Stiefel M, Maloney-Wilensky E, Danish S, Dolinskas C, LeRoux P. Duragen is Effective Dural Substitute: Clinical Experience with 100 cases. American Association of Neurological Surgeons Annual Meeting, April 2003

Porosity supports two critical functions within the dural repair process. First, open pore structure aids in the immediate formation of a biological

seal to protect against CSF leakage. Next, a highly porous collagen scaffold promotes rapid cellular infiltration that allows the neodura to develop

within just two weeks.

The DuraGen Graft Difference

Porosity

DuraGen Grafts Offer Rapid Resorption and Proven Dural Repair With No Reports of Foreign Body Reaction, Graft Encapsulation, or Rejection.

DuraGen graft offers compressable

thickness1 that provides the optimal

porosity (50-150µm) for fibrin clot formation

and cell infiltration to achieve natural

dural repair.

DuraMatrix-Onlay membrane is a highly

compressed matrix with low porosity

(10µm)2 that tends to impede tissue healing

and regeneration and increases the

likelihood of graft encapsulation.

Dura as seen in secondary cranioplasty procedure 6-months after decompressive hemicraniectomy 4

26 Weeks Post Implantation

DuraGen - New Human Dura at 26 Weeks**

Regenerated Dura

No Comparative Images Available To Us For DuraMatrix-OnlayMembrane.

Cranial Margin

DuraGen Graft DuraMatrix Onlay

DuraGen Graft DuraMatrix Onlay

DuraGen Graft DuraMatrix-Onlay Membrane

DuraGen Graft DuraMatrix Onlay

Fibroblasts begin to migrate into the matrix 2-3 days after implantation and start the process of laying down new collagen.

Within two weeks of implantation, a neodural membrane has formed between the dural margins to permanently close the dural defect.

After 6-8 weeks, the implant is resorbed and replaced by neodura.

After 1 year, the neodura has developed into mature dura.

Fibroblasts invade the implant andproduce new collagen at 12 weeks post implantation.3

The implant does not fully resorb for at least 6-9 months2, leaving the patient at risk for foreign body reaction, inflammatory responses,and potential graft encapsulation.

The pore size is optimized to allow fibroblasts to rapidly

enter the matrix and lay down natural collagen fibers.

The 99% porosity, even distribution, and pore

interconnectivity promote uniform tissue regeneration

throughout the matrix.

DuraGen Plus Onlay

“The Fibroblasts Use the Pores on the Matrix to Lay Down Endogenous Collagen. By 6-8 Weeks, the Collagen Matrix (DuraGen

graft) is Resorbed and is Integrated to the Endogenous Dura Mater. The Compact Structure of the (Other) Xenogenic Materials

May Limit the Fibroblast Migration to the Edges or to the Suture Holes. These Processes do not Constitute an Ideal Situation

with Regards to the Sealing Quality of the material.” - Sade B, et al 9

x 100 MagnificationDuraMatrix-Onlay Membrane

Low porosity is inhibitive to cell infiltration.

x 100 Magnification

500 µm500 µm

Page 4: Dural Regeneration Matrix - Integra lifesciences · 2. Stryker Promotional Material #9410-400-152 Rev. A 3. Collagen Matrix, Inc. Promotional Material #CDSLM Rev. 0 4. Heuer G, Stiefel

Integra, the Integra logo, DuraGen and DuraGen Plus are registered trademarks of Integra LifeSciences Corporation in the United States and/or other countries. All other trademarks are trademarks of their respective owners or holders. DuraMatrix-Onlay, and DuraMatrix are registered trademarks of Stryker Corporation. ©2012 Integra LifeSciences Corporation. All rights reserved. Printed in the USA. 0002645

For more information or to place an order, please contact:Integra n 311 Enterprise Drive, Plainsboro, NJ 08536800-997-4868 USA n 609-936-5400 outside USAintegralife.com

Integra® DuraGen®

Competitive Comparison

1 Million Dural Grafts and Counting

12 Million Collagen Implants and Counting

Only Integra DuraGen graft provides the confidence of utilizing a dural matrix which has been implanted over one million times.

Our leading technology collagen products have been implanted over 12 million times in a variety of procedures throughout the world.

Summary outcome statistics derived from the following 1o clinical studies:1. Danish SF, et al: Experience with acellular human dura and bovine collagen matrix for duraplasty after posterior fossa decompression for Chiari malformations.

J Neurosurg Pediatrics 104:16-20, 2006

2. Harvey RJ, et al: Closure of large skull base defects after endoscopic transnasal craniotomy. J Neurosurg 111: 271-329, 2009

3. Horaczek JA, et al: Collagen matrix in decompressive hemicraniectomy. Operative Neurosurgery 63: ONS176-81, 2008

4. Lee JH, et al: Dural reconstruction in meningioma surgery in, Lee JH (ed): Meningiomas: Diagnosis, Treatment and Outcome. London: Springer, 2009, pp 619–624

5. Litvack ZN, et al: Dural augmentation: Part I: evaluation of collagen matrix allografts for dural defect after craniotomy. Neurosurgery 65:890-897, 2009

6. Narotam PK, et al: Collagen matrix (DuraGen) in dural repair: analysis of a new modified technique. SPINE 292:861-2867, 2004

7. Narotam PK, et al: Collagen matrix duraplasty for cranial and spinal surgery: a clinical and imaging study. J Neurosurg 106:45–51, 2007

8. Narotam PK, et al: Collagen matrix duraplasty for posterior fossa surgery: evaluation of surgical technique in 52 adult patients. J Neurosurg 111:380-386, 2009

9. Sade B, et al: Non-watertight dural reconstruction in meningioma surgery: results in 439 consecutive patients and a review of the literature. Clinical article.

J Neurosurg [epub ahead of print August 13, 2010. DOI: 10.3171/2010.7. JNS10460]

10. Stendel R, et al: Efficacy and safety of a collagen matrix for cranial and spinal dural reconstruction using different fixation techniques.

J Neurosurg 109:215-221, 2008

Over 1,400 Patients in 10 Published Clinical Studies

• 0% Foreign Body Response.• 1.9% Infection Rate.• 2.1% Leakage Rate.

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