Integra NERVE REPAIR SOLUTIONS Nerve Guide

Integra®
NeuraGen® Nerve Guide NeuraWrap™ Nerve Protector

NERVE REPAIR SOLUTIONS

Time-Tested. Optimally-Designed. Proven Performance.1,2
Electron Microscopy of NeuraGen® Nerve Guide
Semi-permeable, Smooth, Inner Membrane

Porous Outer Layer

Electrophysiological Recovery4

4040

KEY

3535

3030

2525 2020 15
15 10
10 5 05
0 0

200 400 600 800 1000 1200 1400

0 Tim2e00aft4e0r0ne6rv0e0 re8p0a0ir 1(0d0a0ys1)200 1400

Time after nerve repair (days)

KEY NeuraGNeenuraGen Nerve GNrearfvte Graft Direct SDuirteucret Suture

Motor Action Potential (mV) Motor Action Potential (mV)

Collagen Conduit Designed to Enhance Regenerative Growth Environment • Ideally engineered pore size3 • Controlled rate of resorption4 • Flexible and pliable3 • Compression resistant3
Proven Positive Performance for Peripheral Nerve Repair • Equivalent functional recovery
compared to direct suture1,4 • Equivalent outcomes to nerve graft over short nerve gaps1,5 • Favorable clinical results compared to direct suture and nerve grafting2 • Pre-clinical studies demonstrate superior results over other nerve conduits6

Collagen Experts With an Extended History of Collagen Matrix Innovation
1970 -1980s
Collagen Matrix Development
1985
GENERAL SURGERY Helistat® Absorbable Collagen Hemostatic Sponge
1996
BURN SURGERY Integra® Dermal Regeneration Template
1999
NEUROSURGERY DuraGen® Dural Graft Matrix
2001
PERIPHERAL NERVE SURGERY NeuraGen® Nerve Guide
2002
PLASTIC & RECONSTRUCTIVE Integra™ Bilayer Matrix Wound Dressing
2003
NEUROSURGERY DuraGen Plus® Dural Regeneration Matrix
2004
PERIPHERAL NERVE SURGERY NeuraWrap™ Nerve Protector
2004
PLASTIC & RECONSTRUCTIVE Integra™ Matrix Wound Dressing
2005
PLASTIC & RECONSTRUCTIVE TenoGlide® Tendon Protector Sheet
2007
PLASTIC & RECONSTRUCTIVE Integra™ Flowable Wound Matrix
Over 12M Collagen Implants Distributed7

What is the Problem?
Completely Severed Nerve
Disease State
Compressed, Scarred, or Partially Injured Nerve

What is Our Solution?
NeuraGen® Nerve Guide
Semi-Permeable, Absorbable Type I Collagen Tube
• Protective environment across nerve discontinuities4
• Isolated conduit environment guiding axonal regrowth4
• Absorption via normal metabolic pathways
Indications: NeuraGen® Nerve Guide is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity. Contraindications: NeuraGen Nerve Guide is contraindicated for patients with a known history of hypersensitivity to bovine derived materials.
Intended Use
NeuraWrap™ Nerve Protector
Biocompatible, Highly Purified Type I Collagen Structure
• Nerve protection following decompression procedures3,8
• Nerve isolation in traumatized wound beds3,8
• Closure around partially severed nerves8
Indications: NeuraWrap™ Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue. Contraindications: NeuraWrap Nerve Protector is contraindicated for patients with a known history of hypersensitivity to bovine derived materials.

What is the Process?
Application of NeuraGen Nerve Guide
1. Determine nerve diameter and choose appropriate NeuraGen size
2. After hydrating, pass first suture into the nerve guide
3. Draw nerve stump into the nerve guide and pass suture through the epineurium
4. Flush the lumen of the guide with saline
5. Repeat suturing procedure for the other nerve stump
6. Repeat flushing procedure and complete repair
Precautions • Hemostasis of the nerve stumps must be achieved prior to placement of the NeuraGen Nerve Guide. A blood clot in the
lumen of the nerve guide will impede axon growth. • Tensionless repair technique should be used to prevent tension along the length of the nerve. • NeuraGen Nerve Guide should be used with caution in infected regions.
Surgical Technique*
Application of NeuraWrap Nerve Protector
1. Determine nerve diameter and choose appropriate NeuraWrap size
2. After hydrating, open wrap slit and place over the injured nerve
3. Close slit with a running suture technique
4. Rotate wrap so that the suture line is away from the injured soft tissue
5. Additional stay suture(s) may be placed to prevent migration
6. Complete repair
Precautions • After application, NeuraWrap Nerve Protector must fit loosely around the injured nerve to avoid constriction of the nerve tissue. • NeuraWrap Nerve Protector should be used with caution in infected regions.

Why Use Our Product?
An Efficient Alternative to Nerve Graft or Direct Suture • Eliminates nerve harvest procedure and potential donor
site complications • Simple, rapid entubulation repair minimizes OR time and potential for scar formation and tissue ingrowth4 • Demonstrated functional recovery equivalent to nerve graft and direct suture1,4 • Manufactured from Ultra Pure Collagen™, minimizing pathogenic9
and immuno-rejection concerns10 • Readily available supply, extended shelf-life, dependable and precise sizes available
Benefits
Biocompatible Isolation of Healing Nerves • Generated from Integra’s Ultra Pure Collagen™ technology • Mechanically resists compression from surrounding tissue and excludes scar tissue ingrowth3,4 • Recovers and maintains closure once placed around nerve3,8 • Remains in place during active phase of tissue healing4 • Completely resorbed after tissue response has resolved4

Convenience and Precision Sizing
Off-The-Shelf Availability and Size-Matched to Fit

NeuraGen Nerve Guide Ordering Information

Reference

Description

Diameter (mm)**

PNG130 PNG220 PNG230 PNG320 PNG330 PNG420 PNG430 PNG520 PNG530 PNG620 PNG630 PNG720 PNG730

1.5mm (ID) x 3cm (length) 2mm (ID) x 2cm (length) 2mm (ID) x 3cm (length) 3mm (ID) x 2cm (length) 3mm (ID) x 3cm (length) 4mm (ID) x 2cm (length) 4mm (ID) x 3cm (length) 5mm (ID) x 2cm (length) 5mm (ID) x 3cm (length) 6mm (ID) x 2cm (length) 6mm (ID) x 3cm (length) 7mm (ID) x 2cm (length) 7mm (ID) x 3cm (length)

NeuraWrap Nerve Protector Ordering Information

Reference

Description

Diameter (mm)**

NW320 NW340 NW520 NW540 NW720 NW740 NW1020 NW1040

3mm (ID) x 2cm (length) 3mm (ID) x 4cm (length) 5mm (ID) x 2cm (length) 5mm (ID) x 4cm (length) 7mm (ID) x 2cm (length) 7mm (ID) x 4cm (length) 10mm (ID) x 2cm (length) 10mm (ID) x 4cm (length)

** actual size
NeuraGen Nerve Guide Adverse Events Possible complications can occur with any nerve repair surgical procedure including pain, infection, decreased or increased nerve sensitivity, and complications associated with use of anesthesia.
NeuraWrap Nerve Protector Adverse Events Possible complications can occur with any peripheral nerve surgical procedure including pain, infection, decreased or increased nerve sensitivity, and complications associated with use of anesthesia.
* As the manufacturer of this device, Integra LifeSciences Corporation does not practice medicine and does not recommend this or any other surgical technique for use on a specific patient. The surgeon who performs any procedure is responsible for determining and using the appropriate technique in each patient.
References: 1. Krarup C, Isben A, Boeckstyns M, et al. “Effects of a Collagen Nerve Guide Tube in Patients With a Median or Ulnar Nerve Lesion.” American Association for Hand Surgery Annual Meeting (2011): 99. 2. Taras JS, Nanavati V, Steelman P. Nerve Conduits. J Hand Ther. 2005;18(2):191-197. 3. Data on file at Integra LifeSciences Corporation: CP-01-003. 4. Archibald SJ, Shefner J, Krarup C, et al. Monkey Median Nerve Repaired by Nerve Graft or Collagen Nerve Guide Tube. J Neurosci. 1995:15(5 Pt 2):4109-4123. 5. Krarup C, Archibald SJ, Madison RD. Factors That Influence Peripheral Nerve Regeneration: Electrophysiological Study of the Monkey Median Nerve. Ann Neurol. 2002;51(1):69-81. 6. Waitayawinyu T, Parisi DM, Miller B, et al. A Comparison of Polyglycolic Acid Versus Type 1 Collagen Bioabsorbable Nerve Conduits in a Rat Model: An Alternative to AutoGrafting. J Hand Surg Am. 2007;32(10):1521-1529. 7. Data on file at Integra LifeSciences Corporation. 8. Data on file at Integra LifeSciences Corporation: R-09-1018. 9. Lynn AK, Yannas IV, Bonfield W. Antigenicity and Immunogenicity of Collagen. J Biomed Mater Res B Appl Biomater. 2004Nov15;71(2):343-54. 10. Data on file at Integra LifeSciences Corporation: CP-04-004.
For more information or to place an order, please contact: Integra n 311 Enterprise Drive, Plainsboro, NJ 08536 877-444-1122 USA n 609-275-0500 outside USA n 866-800-7742 fax integralife.com
DuraGen, DuraGen Plus, Helistat, Integra, Integra Dermal Regeneration Template, the Integra Logo, NeuraGen,and TenoGlide are registered trademarks of Integra LifeSciences Corporation. NeuraWrap is a trademark of Integra LifeSciences Corporation. ©2012 Integra LifeSciences Corporation. All rights reserved. Printed in the USA. 10K ER5335-02/12