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 noncellular debris.

Avance® Nerve Graft provides the following key advantages:

  • Three dimensional scaffold for bridging a nerve gap
  • Decellularized 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)

 

NERVE MATTERS

AxoGen strives to broaden the research and knowledge base of peripheral nerve injury and repair by identifying what factors “matter” in nerve repair.  The links below provide information about how processing and structure of nerve repair options may affect outcomes:

Avance® Nerve Graft: Processing Matters

Avance® Nerve Graft: Structure Matters

 

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 the guidelines of the American Association of Tissue Banks (AATB). Additionally, international regulations are followed as appropriate.

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

INDICATIONS FOR USE

Avance® Nerve Graft is 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 in whom 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 utilized to minimize 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-sterilize Avance® Nerve Graft and do not refreeze product if thawed.