integra - smith & nephew€¦ · neuragen ® pre-clinical study neuragen ® surgical...

Document for use in Europe, Middle-East and Africa only.

Integra®

NeuraGen® Nerve guide NeuraWrap™ Nerve protector

Limit uncertainty with advanced collagen solutions for nerve repair and protection

EN

NeuraGen®

Pre-clinical StudyNeuraGen®

Nerve Regeneration Principle

2 Brochure NeuraGen® Nerve guide / NeuraWrap™ Nerve protectorDocument for use in Europe, Middle-East & Africa only.

"Competitive products by NCAs" designed structureThe underlying technology of the NeuraGen® Nerve guide and the NeuraWrap™ Nerve protector is based on the Ultra-Pure Collagen™ implant, specially designed to isolate and to provide an ideal environment for the growth of Schwann cells and the extension of axons, elements responsible for functional recovery following nerve injury.

The Integra's Ultra-Pure Collagen™ Technology minimizes patho-genic and immuno-rejection concerns to allow the success of nerve repair.A,B

Provides for cellular ingrowth and appropriate nutrient diffusion. C,D Enables controlled resorption. Provides mechanical resistance to compression from surrounding tissue.

Allows passage of small molecules (i.e. water, ions, metabolites, nutrients) to support nerve regeneration and prevents the escape of endogenous growth factors (i.e. Nerve Growth Factor).

Provides an environment for the organization of axonal growth. Allows for easy insertion of the nerve stump into the tube.

A porous outer layer Semi-permeable inner membrane Smooth inner membrane

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A. Narotam, Pradeep K., James R. Van Dellen, P. O. Robert, George W. McKinney III, Simon J. Archibald, and Judith O'grady. Dural/meningeal repair product using collagen matrix. U.S.

Patent 5,997,895, issued December 7, 1999.

B. Tyner, Tim R., et al. Effects of collagen nerve guide on neuroma formation and neuropathic

pain in a rat model. The American Journal of Surgery 193.1 (2007): e1-e6.).

C. Li, S-T., Archibald, S.J., Krarup, C., Madison, R. Semipermeable collagen nerve guides for peripheral nerve regeneration. Polymeric materials

science and engineering. Am. Chem. Soc. Proc. 62: 575-582, 1990. D. Li, S-T., Archibald, S.J., Krarup, C., Madison, R. Peripheral nerve repair with collagen conduits. Clinical Materials, 9:195-200, 1992.

Schwann cells

Nutrients Neurotrophic Factors (BDNF, CNTF, NT3, NT4)

Growth Cone on Axon

Nerve Growth Factor

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NeuraGen®

Pre-clinical Study

3Brochure NeuraGen® Nerve guide / NeuraWrap™ Nerve protectorDocument for use in Europe, Middle-East & Africa only.

Animal Study: Proven Positive Performance*

*Monkey median nerve repaired by nerve graft, direct suture or collagen nerve guide tube Number of monkey treated :8

Pre-clinical studyE demonstrates:

• Functional recovery (sensory and motor) equivalent to direct suture repair and short nerve grafting and stable over long time periods (3 to 4 years).

• Significantly faster rate of recovery than sutures (p<0.001).

Implantation of NeuraGen® Nerve guide for the repair of 2 cm deficit of the median nerve in the primate animal model. (Macaca Fasicularis)

Human Study: prospective randomized trial of 43 patients showed that the use of a collagen conduit like NeuraGen proved to be safe for nerve lacerations in the forearm com-pared to standard techniqueMichel E. H. Boeckstyns, MD, Allan Ibsen Sørensen, MD, Joaquin Fores Viñeta, MD, Birgitta Rosén, PhD, Xavier Navarro, MD, Simon J. Archibald, PhD, Josep Valss-Solé, MD, Mihai Moldovan, MD, Christian Krarup, MD. Collagen Conduit Versus Microsurgical Seurorrhaphy: 2-Year Follow-Up of a Prospective, Blinded Clinical and Electrophysiological Multicenter Randomized, Controlled Trial

Study designProspective randomized trial of 43 patients (44 nerve lacerations). Nerve repairs were performed using a collagen tube (Neuragen) or conventional repair (direct fascicular repair or nerve grafting). Nerve tissue losses of more than 20 mm were excluded.

Main resultsTime for nerve repair was significantly longer in control group compared to Neuragen group (27 minutes ± 3 vs. 16 minutes ± 2 respectively, p<0.005). Neurophysiological results at 12 months: distal motor latency significantly longer and compound muscle action potential significantly lower in the Neuragen group compared to control group (p<0.05). Neurophysiological results at 24 months: no difference in the amplitudes, latencies, and conduction velocities between the 2 groups. Rosen hand function at 12 months: motor domain significantly better recovered in control group than in Neuragen group (p<0.05). Rosen hand function at 24 months: no significant difference. Complications: no surgical complication of infection, extrusion of the conduit or other local adverse reaction, or development of a chronic regional pain syndrome.

InterestRandomized controlled study. No difference between the 2 repair techniques after 24 months, a further recovery is observed between 12 months and 24 months in the Neuragen group.

Electrophysiological recovery source: see study ETime after nerve repair (days)

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Nerve graft

Direct Suture

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NeuraGen®


Surgical Application

Application of NeuraGen® Nerve guide

The NeuraGen® Nerve guide is an absorbable collagen tube designed to be an interface between the nerve and the surrounding

tissue and to create a conduit for axonal growth across a nerve gap.

The NeuraGen® Nerve guide offers a rapid method for rejoining severed peripheral nerves, in contrast to conventional

microsurgical techniques.


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Step 1Determine Neuragen® Nerve guide size and hydrate it.

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Step 2: First sutureRecommendation: 7-0 to 10-0 monofilament, non resorbable suture.

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Step 3: Saline flush3

Step 4: Second suture4

Step 5: Final saline flush5

Step 6: Completed repair6

The NeuraGen® Nerve guideProvides a protective environment and conduit for axonal regrowth across a nerve gap.Simple, rapid entubulation repair designed to minimize surgical procedure time and potential for scar formation and tissue ingrowthE,F.Demonstrated functional recovery equivalent to nerve graft and direct suture.Replaces the need for short gap nerve graft and eliminates nerve harvest procedure and potential donor site complications.Readily available supply, extended shelf-life, dependable and precise sizing.

E. Archibald, S. J., Shefner, J., Krarup, C., and Madison, R. D. Monkey median nerve repaired by nerve graft or collagen

nerve guide tube. J. Neurosci., 15(5): 4109-4123, 1995.

F. Madison, R.D., Archibald, S.J. Potential value of synthetic tubes for nerve repair,

in Neurosurgery (2nd Edition). R. H. Wilkins and S. S.

Rengarchary, McGraw-Hill Book Co., New York; 1995.

NeuraGen®


Surgical Technique Example

Removal of Schwannoma

DiagnosisSurgical Removal of a Tibial Nerve Schwannoma.

Patient caseA 49-year old man suffering from a schwannoma on the left posterior tibial nerve**.

Surgical TreatmentThe procedure is performed with regional (spinal) anaesthesia. The patient is placed in the supine position to maximize exposure of the tumor. A skin incision is made over the course of the nerve on the left internal retro-malleolar.

Wound closure is performed in layers and the patient is immobilized with a plaster cast.


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Step 1: Posterior tibial nerve schwannomaDissection continues on malleolar peroneal groove through subcutaneous fat and reveals a solid well-circumscribed mass involving the posterior tibial nerve.

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Step 2: Enucleation of schwannoma and involved fasciclesFirst dissection of the mass is done then a loop magnification is used to allow identification of the fascicles coursing over the tumor and dissection is continued along the nerve. The schwannoma is removed "en bloc".

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Step 3: Nerve gap after neuroma excision, determination of the size of the NeuraGen® Nerve guideThe surgical removing of the tibial nerve schwannoma leads to the sacrifice of a part of the involved nerve fascicles to achieve total removal of the tumor.

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Step 4: Reconstructed tibial nerve - NeuraGen® Nerve guide fixed with sutures 8.0The restoration of the nerve continuity is made with a NeuraGen® Nerve guide of 3 mm diameter and 3 cm length, fixated with sutures 8.0.

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** Clinical case from Dr Deleuze, hand surgeon, Clinique de la Basilique, Brussels, Belgium

NeuraGen®

Pre-clinical StudyNeuraWrap®

Surgical Application

Application of NeuraWrap™ Nerve protector

The NeuraWrap™ Nerve protector is an absorbable collagen implant that provides a non-constricting encasement for injured

peripheral nerves for protection of the neural environment.

The wall of the conduit has a longitudinal slit that allows the NeuraWrap™ Nerve protector to be spread open for easy placement

over the injured nerve.

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Step 1Determine nerve diameter and choose appropriate NeuraWrap™ Nerve protector size.

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Step 2After hydrating, open wrap slit and place over the injured nerve.

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Step 3Close slit with a running suture technique.

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Step 4Rotate wrap so that the suture line is away from the injured soft tissue.

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Step 5Additional stay suture(s) may be placed to prevent migration.

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Step 6Completed repair.

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The NeuraWrap™ Nerve protector:Designed to resist compression from surrounding tissues and to exclude scar tissue ingrowth.G,H,I,

Aims at minimizing potential neuroma formation and subsequent nerve entrapment.Recovers and maintains closure once placed around nerve.Remains in place during active phase of tissue healing.Readily available supply, extended shelf-life, dependable and precise sizing.

NeuraGen® Nerve guide & NeuraWrap™ Nerve protector are:Composed of semi-permeable, porous, highly purified Type I Collagen. Biocompatible, completely absorbable via normal metabolic pathways.Flexible, pliable and compression resistant.With open structure to facilitate suture placement.


NeuraGen®

Pre-clinical StudyNeuraWrap®

Surgical Tecnhique Example

Neurolysis of the medial dorsal cutaneous nerve

DiagnosisChronic pain on the right foot.

Patient caseThe following case involves a 34-year old man with 1½ year history of pain on the right foot following accidental traumatism by crushing*.

Surgical TreatmentExploration of the nerve documented a voluminous neuroma in continuity.

Step 1: Medial dorsal cutaneous nerveThe neuroma is then removed with a part of the nerve.

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Step 2: NeuraWrap™ Nerve protector of 2 mm diameter and 3 cm length wraps the injured nerve.To help the recovery of the nerve and to avoid the recurrence of the neuroma, a NeuraWrap™ Nerve protector is added.

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G. Soltani, Ali M., et al. Revision Decompression and Collagen Nerve Wrap for Recurrent and Persistent Compression Neuropathies of the Upper Extremity. Annals of plastic surgery 72.5 (2014):

572-578.

H. Kim, Paul D., et al. Collagen nerve protector in rat sciatic nerve repair: a morphometric and histological analysis. Microsurgery 30.5 (2010): 392-396.

I. Hibner, Michael, et al. Repeat operation for treatment of persistent pudendal nerve entrapment after pudendal neurolysis. ournal of minimally invasive gynecology 19.3 (2012): 325-330.

J. Bindra, R. P. Clinical usefulness of collagen nerve wrap for peripheral nerve scarring. Bone & Joint Journal Orthopaedic Proceedings Supplement 95.SUPP 19 (2013): 21-21 .

Indications Neurawrap™

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™

NeuraWrap nerve protector is not designed, sold or intended for use except as described in the indications for use and is contraindicated for patients with a known history of hypersensitivity to bovine derived materials.

Indications NeuraGen®

NeuraGen® is indicated for the repair of peripheral nerve dicontinuities where gap closure can be achieved by flexion of the extremity.

Contraindications NeuraGen®

NeuraGen® is not designed, sold or intended for use except as described in the indications for use and is contraindicated for patients with a known history of hypersensitivity to bovine derived materials.


* Case report made by Dr Deleuze, 2008, hand surgeon, Clinique de la Basilique, Brussels, Belgium

NeuraGen® and NeuraWrap™

Ordering Information

NeuraGen® Nerve guide

Catalog Number Size Actual Size

Inner diameter Length (1 unit/case)

PNG130 1.5 mm 3 cm

PNG220 2 mm 2 cm

PNG230 2 mm 3 cm

PNG320 3 mm 2 cm

PNG330 3 mm 3 cm

PNG420 4 mm 2 cm

PNG430 4 mm 3 cm

PNG520 5 mm 2 cm

PNG530 5 mm 3 cm

PNG620 6 mm 2 cm

PNG630 6 mm 3 cm

PNG720 7 mm 2 cm

PNG730 7 mm 3 cm

NeuraWrap™ Nerve protector

Catalog Number Size Actual Size

Inner diameter Length (1 unit/case)

NW320 3 mm 2 cm

NW340 3 mm 4 cm

NW520 5 mm 2 cm

NW540 5 mm 4 cm

NW720 7 mm 2 cm

NW740 7 mm 4 cm

NW1020 10 mm 2 cm

NW1040 10 mm 4 cm

Products available in the following lengths:2 cm3 cm

Products available in the following lengths:2 cm4 cm

Measures given for information only, may vary depending on individuals.

1.5 to 2 mm

5 to 7 mm

3 to 5 mm

3 to 4 mm

1.5 to 2 mm

5 to 7 mm

3 to 5 mm

1.5 to 3 mm

International +33 (0)4 37 47 59 50 n +33 (0)4 37 47 59 25 faxBenelux +32 (0)2 257 4130 n +32 (0)2 253 2466 fax France +33 (0)4 37 47 59 10 n +33 (0)4 37 47 59 29 fax Germany: +49 (0) 2102 5535 6200 n +49 (0)2 102 5536 636 faxSwitzerland +41 (0)22 721 23 00 n +41 (0)22 721 23 99 faxUnited Kingdom +44 (0)1 264 345 781 n +44 (0)1 264 363 782 faxintegralife.eu/contact

Europe, Middle-East, Africa 0086

Integra LifeSciences Services (France)Immeuble Séquoia 2, 97 allée Alexandre BorodineParc technologique de la Porte des Alpes69800 Saint Priest n France

EC REP

Integra LifeSciences Corporation 311 Enterprise DrivePlainsboro, NJ 08536 US n USA

Manufacturer:

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.n Please read carefully the instructions for use. n Non contractual document. Integra reserves the right, without prior notice, to modify the products in order to improve their quality. n Warning: Applicable laws restrict these products to sale by or on the order of a physician.

Additional information for EMEA Customers only: Products mentioned in this document are CE class III. Please contact Integra customer service should you need any additional information on devices classification. All the medical devices mentioned on this document are CE marked according to European council directive 93/42/EEC on medical devices and its relatives, unless specifically identified as “NOT CE MARKED”.

For more information or to place an order, please contact:

NeuraGen, Integra and the Integra logo are registered trademarks of Integra Lifesciences Corporation in the United States and/or other countries. Neurawrap and Ultra Pure Collagen are trademarks of Integra LifeSciences Corporation. ©2015 Integra LifeSciences Corporation. All rights reserved. Last modification: 03/2015. 0301524-1-EN

integra - smith & nephew€¦ · neuragen ® pre-clinical study neuragen ® surgical...

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