MED INFO
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MAT-US-AVAN-0014 V1.0

Important safety information

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.

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