Human peripheral nerve tissue

AVANCE is an acellular nerve scaffold indicated for the treatment of adult and pediatric patients aged one month and older with: • Sensory nerve discontinuity (≤25 mm). • Sensory nerve discontinuity (>25 mm). This indication is approved under accelerated approval based on static two-point discrimination (s2PD) at 12 months in sensory nerve gaps ≤25 mm, which provided empirical evidence to reasonably predict clinical benefit given similarities in pathophysiology and anticipated therapeutic effects. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial. • Mixed and motor nerve discontinuity.

AVANCE is an acellular nerve scaffold intended to restore nerve function in the distal tissue. AVANCE provides structural and biochemical cues for axonal regeneration. The structural cue is provided by the intact endoneurial tubes. The biochemical cue is provided by the basement membrane proteins of the endoneurial tubes. The basement membrane of the endoneurial tubes includes many proteins, such as collagen, laminin, fibronectin, and proteoglycans. The laminin lining the endoneurial tubes of AVANCE has been shown in in vitro assays and animal studies to be bioactive by supporting Schwann cell migration, axon growth cone interactions, and neurite extension. Without the specific bioactive laminin composition, the neuroregenerative capacity is hindered. However, the exact mechanism of action is unknown.

• AVANCE is intended for surgical implantation. • The recommended number of AVANCE required is based on the nerve deficits identified for repair. • AVANCE may be trimmed to accommodate the size of the deficits. Each AVANCE is for implantation in a single patient only. • See full prescribing information for AVANCE preparation and administration instructions.

None. None.

• Procedural Complications – Monitor for procedural complications, including pain, hyperesthesia, infection, implant site swelling, adhesions, hypertrophic scar formation, impaired motor or sensory function, bleeding, and neuroma formation, and manage accordingly. • Transmission of Infectious Diseases – Because AVANCE is made from human donor tissue, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. No cases of transmission of viral diseases, vCJD, or CJD have ever been identified for AVANCE. All infections thought to be transmitted by AVANCE should be reported to Axogen Corporation at 1-888-296-4361.

The most common adverse reactions (incidence ≥2%) were procedural pain (4%) and hyperesthesia (3%).

Store AVANCE at ≤-40°C (≤-40°F) and keep frozen until use. • Do not use AVANCE if any component of the immediate container closure system or commercial carton has been compromised. • Thaw AVANCE to room temperature without heating using room temperature sterile normal saline or Lactated Ringer’s Solution (LRS). Once thawed, it should not be placed back into the freezer.