Avance® Nerve Graft is peripheral nerve allograft for the reconstruction of peripheral nerve discontinuities (severed nerve gaps) in order to guide and structurally support axonal regeneration across a nerve gap caused by traumatic injury or surgical intervention. Avance® Nerve Graft is a decellularized and sterile extracellular matrix (ECM) processed from human peripheral nerve tissue. AxoGen developed the Avance® Nerve Graft by following the guiding principle that the human body created the optimal nerve structure. AxoGen, through its licensing efforts and research, then developed a proprietary method for processing
recovered human peripheral nerve tissue, in a manner that preserves the essential structure of the ECM while cleansing away cellular and noncellular debris. Avance® Nerve Graft provides the natural nerve structure of an autograft and the ease and availability of off-the-shelf products. AxoGen believes that Avance® Nerve Graft is the only commercially available allograft nerve for bridging nerve discontinuities.
Avance® Nerve Graft provides the following key advantages:
- Applies to long and short gap nerve injuries;
- Decellularized and cleansed extracellular matrix;
- Provides a three dimensional scaffold (preserving the inherent and relevant structural characteristics of nerve) for bridging a nerve gap;
- Structurally supports the body's own regeneration process;
- No donor nerve surgery, therefore no loss of donor nerve function;
- Handles similar to an autograft: flexible and pliable;
- Alleviates tension at the repair site;
- Three years shelf life (kept frozen at or below -40° C/F); and
- Supplied sterile in lengths of 15mm to 70 mm and diameters up to 5mm.
Avance® Nerve Graft is comprised of bundles of small diameter tubes that are held together by an outer tube or sheath. Avance® Nerve Graft has been processed to remove cellular and noncellular factors such as cells, fat, blood, axonal debris and chondroitin sulfate proteoglycans while preserving the three dimensional scaffold and basal lamina tubular structure of the peripheral nerve. This design results in a product that is clean and has clear pathways for axons to grow through. After processing, Avance® Nerve Graft is flexible and pliable, and its open tubular ECM structure can be sutured in place allowing for tension-free approximation of the proximal and distal peripheral nerve stumps. During the healing process, the body revascularizes and gradually remodels the graft into the patient's own tissue while allowing the graft to physically support axonal growth across the nerve discontinuity.
Avance® Nerve Graft is offered in a variety of sizes with lengths between 15mm and 70mm and diameters up to 5mm. This allows the surgeon to choose the correct length for the relevant nerve gap, as well as to match the diameter to the proximal and distal end of the severed nerve. Avance® Nerve Graft is stored frozen at or below -40° C/F and utilizes packaging that maintains the graft in a sterile condition. The packaging is typical for medical products so the surgical staff is familiar with opening the package for transfer of the Avance® Nerve Graft into the sterile surgical field. Additionally, to protect the product during transit and storage, Avance® Nerve Graft is placed inside a hard plastic clamshell that also provides a reservoir for the addition of sterile fluid to aid in thawing the product. The Avance® Nerve Graft thaws in less than 10 minutes, and once thawed, it is ready for implantation.
Avance® Nerve Graft is a human tissue for transplantation. It is processed and distributed in accordance with FDA for Human Cells, Tissues, and Cellular and Tissue-based Products regulations (21 CFR Part 1271), State regulations and the guidelines of the American Association of Tissue Banks (AATB).
This graft is to be dispensed only by, or on the order of, a licensed physician.
APPLICATIONS FOR USE
Avance® Nerve Graft is allograft tissue for bridging peripheral nerve discontinuities.
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.
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® Nerve Graft cannot be guaranteed to be free of all pathogens.
Do NOT reuse or re-sterilize.
Do NOT refreeze product if thawed.