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warnings and cautions
5 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. ( 5.1 ) • 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. ( 5.2 ) 5.1 Procedural Complications Procedural complications have occurred with the AVANCE implantation procedure and have included pain, hyperesthesia, infection, implant site swelling, adhesions, hypertrophic scar formation, impaired motor or sensory function, bleeding, and neuroma formation [see Adverse Reactions ( 6 )] . Additional procedural complications may include risk of bleeding and complications related to anesthesia. Monitor patients for procedural complications with AVANCE implantation and manage accordingly. 5.2 Transmission of Infectious Diseases Transmission of infectious diseases or agents may occur with AVANCE administration, as it is manufactured using tissues from human cadaveric donors. Donors are screened and tested for Human Immune-deficiency Virus 1 (HIV-1); Human Immune-deficiency Virus 2 (HIV-2); Hepatitis B Virus (HBV); Hepatitis C Virus (HCV); and Syphilis (Treponema pallidum). Additional testing for Human T-cell Leukemia-lymphoma Virus 1 (HTLV-1) and Human T-cell Leukemia-lymphoma Virus 2 (HTLV-2) may be performed as required by local regulatory authorities in US states. Only screening was performed for Creutzfeldt-Jakob disease (CJD). These measures do not eliminate the risk of transmitting these or other infectious diseases or agents. All infections thought to be transmitted by AVANCE should be reported to Axogen Corporation at 1‑888-296-4361.
6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥2%) were procedural pain (4%) and hyperesthesia (3%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Customer Care at 1-888-296-4361 or customercare@axogeninc.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in one clinical trial cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice. The safety database described in this section reflects exposure to AVANCE in the RECON Study. A total of 112 patients received AVANCE and 108 patients received NeuraGen ® (bovine nerve cuff) and were followed for a duration of 12 months. [see Clinical Studies ( 14 )] . A serious adverse reaction occurred in 1 patient, which was wound dehiscence. Table 2 lists the most common adverse reactions that occurred in ≥ 2% of patients in the RECON Study. Table 2. Adverse Reactions occurring in > 2% of Patients in the RECON Study Adverse Reactions AVANCE n = 112 n (%) Bovine Nerve Cuff n = 108 n (%) Implant site hyperesthesia 3 (3) 5 (5) Procedural pain 4 (4) 0 Other clinically significant adverse reactions that occurred in <2% of patients in AVANCE group include: implant site swelling (n=2), paraesthesia (n=2), hypertrophic scar (n=2), pyogenic granuloma (n=2), grade 3 neuroma (n=1), wound dehiscence (n=1), tendon adhesion (n=1), implant site nodule (n=1), osteomyelitis (n=1), and dermal cyst (n=1). 6.2 Postmarketing Experience Adverse Reactions from Observational Studies The safety of AVANCE was evaluated in an ongoing, multicenter, observational registry study in patients undergoing nerve repair. The registry assessed repairs using the Medical Research Council Classification (MRCC) across nerve types (sensory, motor, and mixed), gap lengths (5–210 mm), and body regions (upper extremity, head and neck, torso including breast, and lower extremity). Adverse reactions reported in the study include neuroma, seromas, implant site infection, tissue necrosis, nerve regeneration failure, hyperesthesia, hypoesthesia, AVANCE implantation error, and hematoma.