Focus of the Report: This report addresses the use of processed nerve allografts (Avance Nerve Graft) for repair of peripheral nerve discontinuities.
Technology Description: The Avance Nerve Graft is a processed nerve allograft intended for bridging nerve discontinuities to support regeneration of axons. The nerve graft is a sterile donor peripheral nerve that has undergone a cleansing process that removes cells, cellular debris, and certain proteins while preserving the extracellular matrix. Avance is available in multiple lengths and diameters and is stored at or below –40°C for up to 3 years. The thawed graft is surgically implanted and secured in place by sutures to connect the proximal and distal ends of a transected nerve.
Controversy: Direct suture repair may be employed to repair short gaps (< 5 mm) in a nerve and allow nerve regeneration to occur. However, larger nerve gaps cannot be repaired by direct suturing due to the resultant excessive tension between nerve stumps. While autologous nerve graft is the standard of care for repairing nerve gaps of up to 5 centimeters (cm) in length, the procedure has numerous shortcomings and the success rate is limited to sensory function, with only approximately 50% of patients achieving satisfactory results. Nerve grafts most commonly use the sural nerve in the leg, which is a sensory nerve that may not be useful for motor nerve or mixed nerve injuries. Other shortcomings of autologous nerve graft include nerve size mismatch, the need for 2 surgical sites, donor site morbidity, limited supply of donor nerve, scarring, and increased recovery time. Nerve gaps measuring > 5 cm require the use of an allograft from cadaveric or donor nerve tissue. Avance Nerve Graft has emerged as a potential substitute for autologous nerve grafting, with purported efficacy and reduction of the morbidity associated with donor grafts.
Key Questions:
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Is the Avance Nerve Graft effective in treating peripheral nerve discontinuities?
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How does this technology compare with alternative methods (i.e., autografts, nerve conduits)?
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Is the Avance Nerve Graft safe?
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Have definitive patient selection criteria been identified for the Avance Nerve Graft?
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