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MAT-US-AVAN-0014 V1.0
Important Safety Information
Indications
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); Approved under accelerated approval based on static two-point discrimination (s2PD) at 12 months in sensory nerve gaps ≤25 mm, which reasonably predicts clinical benefit. Continued approval may be contingent upon confirmatory clinical trial results.
- Mixed and motor nerve discontinuity; Approved under accelerated approval based on s2PD outcomes in sensory nerves; continued approval may be contingent upon confirmatory clinical trial results.
Warnings and Precautions
- 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. All infections thought to be transmitted by AVANCE should be reported to Axogen Corporation at 1-888-296-4361.
Adverse Reactions
The most common adverse reactions (≥2%) were procedural pain (4%) and hyperesthesia (3%). A serious adverse reaction (wound dehiscence) occurred in 1 patient.