Axoguard Nerve Protector

Axoguard Nerve Protector is the only porcine submucosa extracellular (ECM) matrix surgical implant used to protect injured nerves and to reinforce nerve reconstruction while preventing soft tissue attachments. The Axoguard multi-laminar ECM is designed to minimise the potential for soft tissue attachment and nerve entrapment by physically isolating the nerve during the healing process*(1-3). The SIS material that composes Axoguard provides an open, porous structure that allows for cell infiltration and vascularisation, gradually remodelling and incorporating into the patient’s own tissue*†(1,4-9). Axoguard Nerve Protector is provided sterile and in a variety of sizes to meet the surgeon’s and anatomical needs.

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Axoguard nerve protector can be used to:

  • Protect and isolate injured nerves up to 40 mm
  • Minimise risk of entrapment in compressed nerves
  • Protect partially severed nerves
  • Reinforce a coaptation site

Axoguard nerve protector has the following key advantages:

  • The SIS material that composes Axoguard exhibits better revascularisation compared to a purified collagen matrix*7
  • The material is revascularised, gradually remodelled and incorporated into a connective tissue structure much like the nerve epineurium when used in nerve repair*1,4
  • Allows for nerve gliding, providing non-constricting protection for peripheral nerves1,2-3,10
  • Provides a protective barrier to axonal escape2,11-15
  • Strong and flexible material that is easy to handle, trim and suture during use†16
  • Semi-translucent material enables visual confirmation of the nerve16-17

*As shown in animal models
†As shown in bench models

Regulatory Classification: Axoguard Nerve Protector is a CE Marked medical device.

indications for use

The Axoguard Nerve Protector is indicated for the repair of peripheral nerve injuries where there is no gap. The device is supplied sterile and is intended for one-time use.

contraindications

This device is derived from porcine source and should not be used for patients with known sensitivity to porcine material.

references

  1. Kokkalis ZT, Pu C, Small GA, Weiser RW, Venouziou AI, Sotereanos DG. Assessment of processed porcine extracellular matrix as a protective barrier in a rabbit nerve wrap model. J Reconstr Microsurg. 2011;27(1):19-28.
  2. Zoldos J, Safa B, Niacaris TR, Weber RV, Cho M, Buncke GM. Outcomes from peripheral nerve repair using processed nerve allograft combined with nerve protectors. Paper presented at: 2017 Annual Meeting of the American Association for Hand Surgery; January 2017; Waikoloa, HI.
  3. Bibbo C, Rodriguez-Colazzo E. Nerve Transfer With Entubulated Nerve Allograft Transfers to Treat Recalcitrant Lower Extremity Neuromas. J Foot Ankle Surg. 2017;56(1):82-86.
  4. Record RD, Hillegonds D, Simmons C, et al. In vivo degradation of 14C-labeled small intestinal submucosa (SIS) when used for urinary bladder repair. Biomaterials. 2001;22(19):2653-2659.
  5. Kehoe S, Zhang XF, Boyd D. FDA approved guidance conduits and wraps for peripheral nerve injury: a review of materials and efficacy. Injury. 2012;43(5):553-572.
  6. Brown-Etris M, Cutshall WD, Hiles MC. A New Biomaterial derived from Small Intestine Submucosa and Developed into a Wound Matrix Device. Wounds. 2002;14(4):150-166.
  7. Nihsen ES, Johnson CE, Hiles MC. Bioactivity for small intestinal submucosa and oxidized regenerated cellulose/collagen. Adv Skin Wound Care. 2008;21(10):479-486.
  8. Hodde J, Janis A, Ernst D, Zopf D, Sherman D, Johnson C. Effects of sterilization on an extracellular matrix scaffold: part I. Composition and matrix architecture. J Mater Sci Mater Med. 2007;18(4):537-543.
  9. Ko YG, Park JH, Lee JB, et al. Growth behavior of endothelial cells according to electrospun poly(D,L-lactic-co-glycolic acid) fiber diameter as a tissue engineering scaffold. Tissue Eng Regen Med. 2016;13(4):343-351.
  10. Papatheodorou LK, Williams BG, Sotereanos DG. Preliminary results of recurrent cubital tunnel syndrome treated with neurolysis and porcine extracellular matrix nerve wrap. J Hand Surg Am. 2015;40(5):987-992.
  11. Perretta D, Green S. Bridging the Gap in Peripheral Nerve Repair. Bull Hosp Jt Dis (2013). 2017;75(1):57-63.
  12. Safa B, Buncke G. Autograft Substitutes: Conduits and Processed Nerve Allografts. Hand Clin. 2016;32(2):127-140.
  13. Ducic I, Fu R, Iorio ML. Innovative treatment of peripheral nerve injuries: combined reconstructive concepts. Ann Plast Surg. 2012;68(2):180-187.
  14. Zuniga JR. Sensory outcomes after reconstruction of lingual and inferior alveolar nerve discontinuities using processed nerve allograft – a case series. J Oral Maxillofac Surg. 2015;73(4):734-744.
  15. Ducic I, Felder JM, Dellon AL. Diagnosis and treatment of painful neuroma and of nerve compression in the lower extremity. In: Song DH, Neligan PC, Liu DZ, eds. Plastic Surgery: Lower Extremity, Trunk, and Burns. Vol 4. 4th New York, NY: Elsevier; 2018;143-165.
  16. Axogen Internal Document VP-131 R00 Report
  17. Ducic I, Safa B, DeVinney E. Refinements of nerve repair with connector-assisted coaptation. Microsurgery. 2017;37(3):256-263.

david’s story

Following his 49th marathon, David suffered from a compressed peroneal nerve, rendering it difficult to walk, much less run. His peroneal nerve was decompressed and wrapped using Axoguard Nerve Protector. David recently completed his 50th marathon.

See story

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