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CLINICAL EVIDENCE SUMMARY

Integra®

Peripheral Nerve Portfolio

RES

ULT

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NERVE GAP LENGTH

Reconstruction of Digital Nerves With Collagen Conduits1

AUTHOR(S) Taras JS, Jacoby SM, Lincoski CJ

OBJECTIVE To evaluate clinical outcomes in patients where type I collagen nerve conduits, NeuraGen® Nerve Guide, were used for nerve repair in 22 isolated digital nerve lacerations.

HYPOTHESIS The researchers hypothesized that collagen conduits are an effective option for the reconstruction of lacerated digital nerves unsuitable for direct repair.

STUDY DESIGN Prospective, non-comparative, single practice, 19 patient study evaluating safety and performance outcomes followed for an average of 20 months postoperatively, measured with static and moving 2PD tests, and VAS pain scores. Level of evidence = 4.

SUMMARY Nineteen patients with 22 proper digital nerve lacerations underwent nerve repair using NeuraGen Nerve Guides when the nerve gap was intraoperatively measured at < 2cm and primary repair would result in undue tension. The average time of surgery after injury was 6 days (range 1-19 days). All patients recovered protective sensation. S2PD mean score measured 5.2mm; M2PD score measured 5.0mm. 73% of satisfaction scores were graded at least good to excellent. There were no complications.

STUDY 1 - NO NEUROMA FORMATIOND

ETA

ILS

Reflected as Outcome Measurement for M2PD and S2PD

The authors state this study confirms... that collagen conduits reliably provide a repair that restores nerve function for nerve gaps measuring less than 2 cm.

STUDY OUTCOME...data suggest that collagen conduits offer an effective method of reconstructionfor digital nerve lacerations.1

Test group:Conduit repair of small to short gap digital nerves

Avg. gap length 12mm

Range 5-17mm19 patients fulfilled

the inclusion criteria

20 monthsRange 12-59

FOLLOW-UP PATIENTSREPAIR TYPE

GRADED SATISFACTION RESULTS

Excellent Good Fair Poor

59% 14% 27% 0%

100% patients recovered protective sensation

73% of repaired digital nerves had at least good to excellent results

There were no complications, infections, inflammation, or digital stiffness at final follow-up.

There was no painful neuroma formation or nerve sensitivity at final follow-up

1284333-1-ENIntegra® Peripheral Nerve Portfolio - Clinical Evidence Summary CLINICAL RESULTS MAY VARY

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NERVE GAP LENGTH

Type I Collagen Nerves in the Forearm Conduits for Median Nerve Repairs in the Forearm2

AUTHOR(S) Dienstknecht T, Klein S, Vykoukal J, Gehmert S, Koller M, Gosau M, Prant lL

OBJECTIVE To evaluate clinical outcomes in patients with median nerve damage in the distal forearm where type I collagen nerve conduits, NeuraGen® Nerve Guide, was used for nerve repair in 9 patients with large-diameter nerve gaps.

HYPOTHESIS The researchers hypothesized that Type I collagen conduits would be suitable for bridging traumatic nerve gaps of less than 2 cm in lacerated median nerves of the forearm.

STUDY DESIGN Prospective, non-comparative/single arm, single surgeon, 9 patient study evaluating safety and performance outcomes measured with nerve conduction velocities, VAS pain scores, DASH scores and performance on S2pd tests. Level of evidence = 4.

SUMMARY Nine patients with median nerve gaps measuring 1 to 2 cm following traumatic laceration underwent entubulation nerve repair within 18 hours of the injury. Patient ages ranged from 10 yrs to 41 yrs. Conduit diameter ranged from 4mm to 7mm. Outcomes were measured at a mean follow-up of 21 months. Motor responses were found to be 64% of the contralateral healthy limb. Static 2PD results showed excellent sensory recovery in 2 patients (<6mm), satisfactory sensory recovery in 4 patients (6-10) and poor results in the final 3 patients.

DET

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M0 = No muscle strength M5 = Full muscle strength

1 did not report for final follow-up

In this study.... 67% of the patients had functional sensory recovery of the injured nerve after collagen conduit repair.

8 of 9 patients were satisfied with the procedure and would undergo surgery again.

STUDY OUTCOMEThis study indicates that purified type 1 bovine collagen conduits are a practical and efficacious method for the repair of median nerves in the distal forearm.2

STUDY 2 - NO NEUROMA FORMATION

Test group:Entubulation of smallgap, large-diametermedian nerves using

NeuraGen

Between1 to 2 cm

patients fulfilled the inclusion criteria

14 monthminimum

FOLLOW-UP PATIENTSREPAIR TYPE

CONDUIT REPAIR OF SMALL TO SHORT GAP, LARGE-DIAMETER MEDIAN NERVES

22%

33% 45%

M3 = 33%

M4 = 45%

M5 = 22%

9

Average muscle strength measured at M3.9

No painful neuromas, tender scars or revisions reported

Patients demonstrated good motor functioning in clinical and nerve conduction velocity measurements

1284333-1-ENIntegra® Peripheral Nerve Portfolio - Clinical Evidence Summary CLINICAL RESULTS MAY VARY

Conduit Repairs(n=19)

Direct Suture Repairs(n=13)

Collagen Conduit Versus Microsurgical Neurorrhaphy: 2-Year Follow-Up of a Prospective, Blinded Clinical and Electrophysiological Multicenter Randomized, Controlled Trial 3

AUTHOR(S) Boeckstyns MEH, Sorensen AI, Vineta JF, Rosen B, Navarro X, Archibald SJ, Valss-Sole J, Moldovan M, Krarup C

OBJECTIVE Comparison of collagen tube versus conventional repair (direct suture or nerve grafting) of acute lacerations of mixed sensory-motor nerves in humans.

HYPOTHESIS The researchers hypothesized that the use of Collagen Nerve Guide Conduit for repair of traumatic nerve lesions in human, leaving a gap no greater than 6mm between the nerve ends within the conduit, would allow recovery of sensory and motor functions that would be at least equivalent to that after conventional repair (direct suture or nerve grafting).

STUDY DESIGN Integra-sponsored, Post-Market Clinical Follow-Up, prospective, randomized, controlled trial comparing repair outcomes using collagen nerve guide conduits versus direct suture or nerve grafts for nerve gaps that did not exceed 20mm or 6mm between nerve ends within the tube. Level of evidence = 2.

SUMMARY Thirty-one adult patients underwent 32 complete laceration nerve repairs of the median or ulnar nerves in the distal third of the forearm within 72 hours of injury. The subjects were randomized at the time of surgery following nerve gap measurements used to determine suitability for direct end-to-end suture repair vs collagen conduit repair with no gaps exceeding 20mm. Follow-up evaluators were blinded. It was confirmed the use of Collagen Nerve Guide Conduits for repair of nerve lacerations is associated with recovery of sensory and motor functions that are equivalent to direct suture at 24 months. The time for nerve repair was +/- 16 2 minutes in the conduit group versus +/- 27 3 minutes in the control group (P ≤ .005).

STUDY 3 - LESS O.R. TIMER

ESU

LTS

DET

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Primary efficacy parameter at 24 month follow-up: Compound motor action potential

Secondary efficacy parameters at 24 month follow-up:Sensory function, discomfort, or motor function and

pain/discomfort.

No significant sensory difference for direct suture vs conduit at 24 months

In this study ... the use of collagen conduits produced recovery of sensory and motor functions equivalent to direct suture at 24 months after repair when the nerve gap inside the tube was 6mm or less.

There were no local adverse reactions detected.

STUDY OUTCOMESA semipermeable membrane also allows for exclusion of fibrogenic cells responsible for fibrosis and scar formation from entering the repair site.3

Test group:Conduit repair of mixed

motor sensory nerve

Control Group: Direct suture

*further measurements not recorded

<= 20 mm 12 and 24 months

FOLLOW-UP PATIENTSREPAIR TYPE

40% less time in the OR than direct suture

NERVE GAP LENGTH

32# OF NERVE

REPAIRS

31# OF PATIENTS

1284333-1-ENIntegra® Peripheral Nerve Portfolio - Clinical Evidence Summary CLINICAL RESULTS MAY VARY

STUDY 4 & 5RECURRENT COMPRESSION NEUROPATHY OUTCOMES

STUDIES OBJECTIVES To evaluate the use of collagen nerve wraps during external neurolysis procedures of the upper extremity

UNIVERSAL PROBLEM STATEMENT

Recurrent or persistent compression neuropathies of the upper extremity, including carpal and cubital tunnel syndrome, present a difficult treatment challenge to the hand or peripheral nerve surgeon.4 Scar tissue formation after the primary operation leads to recurrence of symptoms, in addition to deteriorated nerve compression and disruption of the nerve’s vascular supply.5

Carpal tunnel syndrome treatment related complications and failures may

occur in up to 32% of the cases.5

32%

Title: Revision Decompression and Collagen Nerve Wrap for Recurrent and Persistent Compression Neuropathies of the Upper Extremity

Details: Retrospective Analysis, 5 year period, 15 patients, mean age 63 (35-86).

Results: Using a collagen matrix wrap in recurrent compression neuropathies with good success. The collagen wrap allows nerve gliding, protection from perineural scar formation, and a favorable microenvironment.

Title: Median Nerve Biodegradable Wrapping: Clinical Outcome of 10 Patients

Details: Prospective, comparative study, 10 patients with previous surgical intervention for Carpal Tunnel Syndrome underwent revision surgery and median nerve protection with a biodegradable collagen nerve wrap.

Results: By using this technique and a nerve protector, all [10] patients experienced complete resolution of symptoms without evidence of recurrence.

USE OF COLLAGEN WRAPS

89% of patients with revision carpal tunnel decompression demonstrated resolution or improvement in the carpal

tunnel symptoms

Those with revision cubital tunnel decompression

had an 83% resolution or improvement of symptoms

89% 83%

The incidence of recurrent or persistent cubital tunnel syndrome has been

estimated to be around 25%.4

25%

The collagen wrap allows nerve gliding, protection from perineural scar formation, and a favorable microenvironment.4

STU

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4ST

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1284333-1-ENIntegra® Peripheral Nerve Portfolio - Clinical Evidence Summary CLINICAL RESULTS MAY VARY

Integra Peripheral Nerve PortfolioClinical Evidence Summary

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NeuraGen, Integra, and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. NeuraWrap is a trademark of Integra LifeSciences Corporation or its subsidiaries. All other trademarks and trade names are the property of their respective owners. ©2019 Integra LifeSciences Corporation. All rights reserved. Printed in USA. 0M 1284333-1-EN

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 Non contractual document. The manufacturer 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.n Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

** actual size

NeuraGen® Nerve Guide Ordering Information

Reference Description Diameter (mm)**

PNG130 1.5mm (ID) x 3cm (length)

PNG220 2mm (ID) x 2cm (length)

PNG230 2mm (ID) x 3cm (length)

PNG320 3mm (ID) x 2cm (length)

PNG330 3mm (ID) x 3cm (length)

PNG420 4mm (ID) x 2cm (length)

PNG430 4mm (ID) x 3cm (length)

PNG520 5mm (ID) x 2cm (length)

PNG530 5mm (ID) x 3cm (length)

PNG620 6mm (ID) x 2cm (length)

PNG630 6mm (ID) x 3cm (length)

PNG720 7mm (ID) x 2cm (length)

PNG730 7mm (ID) x 3cm (length)

NeuraWrap™ Nerve Protector Ordering Information

Reference Description Diameter (mm)**

NW320 3mm (ID) x 2cm (length)

NW340 3mm (ID) x 4cm (length)

NW520 5mm (ID) x 2cm (length)

NW540 5mm (ID) x 4cm (length)

NW720 7mm (ID) x 2cm (length)

NW740 7mm (ID) x 4cm (length)

NW1020 10mm (ID) x 2cm (length)

NW1040 10mm (ID) x 4cm (length)

References: 1. Taras JS, Jacoby SM, Lincoski, MD. Reconstruction of Digital Nerves with Collagen Conduits. J Hand Surg. 2011;36A:1441-1446. 2. Dienstknecht T. MD, Klein S. MD, Vykoukal J. PhD, Gehmert S. MD, Koller M. PhD, Gosau M. MD, Prantl L. MD: Type I Collagen Nerve Conduits for Median Nerve Repairs in the Forearm. J Hand Surg 2013;38A:1119–1124. 3. Michel E. H. Boeckstyns, MD, Allan Ibsen Sørensen, MD; et al. “Collagen Conduit Versus Microsurgical Neurorrhaphy: 2 year follow up of prospective, blinded clinical and electrophysiological multicenter randomized controlled trial”. J Hand Surg 2013. 4. Soltani AM. MD, Allan BJ. MD, Best MJ. MD, Mir HS. MD, Panthaki ZJ. MD “Revision Decompression and Collagen Nerve Wrap for Recurrent and Persistent Compression Neuropathies of the Upper Extremity”. A Plastic Surgery, 2014; 72:572-578.) 5. Kokkalis ZT., Mavrogenis AF., Vottis C., Papatheodorou L., Papagelopoulos PJ., Soucacos PN., Sotereanos DG.,: “Median Nerve Biodegradabel Wrapping: Clinical Outcome of 10 Patients.” Acta Orthopaedica Belgica, 2016; 82:351-357.

* 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.

NeuraGen® Nerve Guide Description: NeuraGen nerve guide is an absorbable implant for the repair of peripheral nerve discontinuities. NeuraGen nerve guide provides a protective environment for peripheral nerve repair after injury, and is designed to be an interface between the nerve and surrounding tissue and to create a conduit for axonal growth across a nerve gap. When hydrated, NeuraGen nerve guide is an easy to handle, soft, pliable, nonfriable, porous collagen tube. Indications For Use: 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 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. 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 Description: NeuraWrap nerve protector is an absorbable collagen implant that provides a non-constricting encasement for injured peripheral nerves for protection of the neural environment. NeuraWrap nerve protector is designed to be an interface between the nerve and the surrounding tissue. When hydrated, NeuraWrap nerve protector is an easy to handle, soft, pliable, nonfriable, porous collagen conduit. The resilience of the collagen conduit allows NeuraWrap nerve protector to recover and maintain closure once the device is placed around the nerve. Indications For Use: 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 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 materialsAdverse 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.

** actual size

CLINICAL RESULTS MAY VARY