Avance Nerve Graft

Avance Nerve Graft is an off-the-shelf processed human nerve allograft intended for the surgical repair of peripheral nerve discontinuities. Through a proprietary cleansing process for recovered human peripheral nerve tissue, the graft preserves the essential inherent structure of the ECM while cleansing away cellular and non-cellular debris.

  • To Order
  • Contact your local distributor for ordering information.

Avance Nerve Graft provides the following key advantages:

  • Three-dimensional scaffold for bridging a nerve gap
  • Decellularised and cleansed extracellular matrix that remodels into patient’s own tissue
  • No donor nerve surgery, therefore no comorbidities associated with an additional surgical site
  • Available in a variety of lengths and diameters to meet a range of gap lengths and anatomical needs

Supplied sterile with three years shelf life (kept frozen at or below -40º C/F).

regulatory classification

Avance Nerve Graft is a human tissue for transplantation. Avance Nerve Graft is processed and distributed in accordance with US FDA requirements for Human Cellular and Tissue-based Products (HCT/P)under 21 CFR Part 1271 regulations, US State regulations, and applicable international regulations. Axogen Corporation is accredited by the American Association of Tissue Banks (AATB). In the EU, Axogen works with importing Tissue Banks to obtain approval to import nerve tissue with the country’s competent authorities responsible for human tissue. Please contact your distributor to obtain their documentation on approval. Axogen processes human tissue under systems that are compliant to Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, Commission Directive 2006/86/EC of 24 October 2006 implementing Directive, 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells and Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells.

This graft is to be dispensed only by or on the order of a licensed physician.

indications for use

Avance Nerve Graft is a processed nerve allograft (human) intended for the surgical repair of peripheral nerve discontinuities to support regeneration across the defect.

contraindications

Avance Nerve Graft is contraindicated for use in any patient whose soft tissue implants are contraindicated. This includes any pathology that would limit the blood supply and compromise healing or evidence of a current infection.

warnings

Careful donor screening, laboratory testing, tissue processing and gamma irradiation have been used to minimise the risk of transmission of relevant communicable diseases to the patient. As with any processed human donor tissue, Avance cannot be guaranteed to be free of all pathogens. Do not reuse or re-sterilise Avance Nerve Graft and do not refreeze product if thawed.

Jeffrey’s story

Jeffrey suffered severe damage to his left ulnar nerve when struck by gunfire while serving in Afghanistan. His ulnar nerve was repaired using Avance Nerve Graft and Axoguard Nerve Protector. Jeffrey is now a medically retired US Marine happily working as a park ranger.

See story

Disclaimer: Not all products are available in every country.