What is regenerative medicine?
Regenerative medicine enables the repair, restoration, replacement or regeneration of tissue or organ systems of the body. It generally consists of two components—a scaffold or ExtraCellular Matrix (ECM) to support the cells and/or provide the architecture of the tissue and cells to regenerate or recellularize the scaffold. Regenerative medicine products may be one or both of these components. For example, a bone allograft material for spinal fusions provides the scaffold to fill the void but relies on the patient’s own cells to regenerate the bone.
AxoGen's proprietary licensed and patent-protected technologies decellularize tissue while preserving the ExtraCellular Matrix. In particular the Avance® Nerve Graft process decellularizes donated human nerve tissue while preserving the critical microstructure of the nerve. After surgical implantation, this scaffold or nerve ExtraCellular Matrix is recellularized by the patient’s own body.
What are peripheral nerves?
Peripheral nerves are the nervous system outside of the brain, spinal cord and central nerves. The peripheral nerves function like the wires of the body: they connect and provide the signals to and from the central nervous system to the muscles, organs and sensory receptors. Transection or compression of the peripheral nerves can result in the loss of downstream functions and/or pain.
What is a peripheral nerve graft?
When a peripheral nerve is fully transected, the patient loses all of the function of the nerve. There is virtually no chance of recovery without a surgical intervention for a fully transected nerve. Surgeons will attempt to surgically align the severed nerve ends without putting tension on the nerve. If there is a gap between the nerve ends, a bridge or scaffold is typically required to support the nerve regeneration across the gap. Avance® Nerve Graft is donated and processed human peripheral nerve. It can be used by surgeons to provide the bridge between the severed nerve ends. Other alternatives are an autograft (a nerve transplanted from elsewhere in the patents own body) or a nerve conduit (a hollow tube used to connect the nerve ends when the gap is small).
What is an autograft?
An autograft is a surgical implant of tissue transplanted from one part of the body to another in the same patient. The patient has a second surgical injury to repair the more critical primary injury. In the case of a nerve autograft, the patient loses the function of the donor nerve, the procedure may add increased operative time and it may result in additional scarring, risk of complications such as infection due to the additional surgical site. Even with these drawbacks, nerve autografts have been the gold standard for bridging transected nerves.
What is an allograft?
An allograft is a surgical implant of tissue transplanted into one individual from another individual. Avance® Nerve Graft is a decellularized nerve allograft. While Avance® Nerve Graft is similar to peripheral nerve autografts in structure, flexibility and pliability, no donor nerve surgery is required for use. Therefore, the patient does not suffer the loss of the donor nerve function as well as the pain and scar resulting from the additional autograft surgery.
What is a nerve conduit?
A nerve conduit is a natural or synthetic single tube-like structure used in tension-free peripheral nerve repair. Such a conduit is typically an absorbable hollow tube that, unlike natural nerve, does not have multiple basal lamina tubes (the microarchitecture of the nerve) to support regenerating axons. Hollow-tube conduits may also lack pliability, structural integrity and may be difficult to use in a confined space. Additionally, hollow-tube conduits do not provide familiar handling characteristics to surgeons and sometimes are contraindicated for use in infected wound beds. Clinical data has demonstrated that conduits are most effective only when used in very short gaps and successful nerve recovery is diminished when used beyond their effective range.
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