Processed nerve allograft

1 INDICATIONS AND USAGE 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). ( 1 ) • 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. ( 1 , 14 ) • Mixed and motor nerve discontinuity. This indication is approved under accelerated approval based on s2PD at 12 months in sensory nerve gaps, 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. ( 1 , 14 ) 1.1 Sensory Nerve Discontinuity (≤25 mm) AVANCE is indicated for the treatment of adult and pediatric patients aged one month and older with sensory nerve discontinuity ≤25 mm. 1.2 Sensory Nerve Discontinuity (>25 mm) AVANCE is indicated for the treatment of adult and pediatric patients aged one month and older with peripheral sensory nerve discontinuity >25 mm. This indication is approved under accelerated approval based on improvement in 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. [see Clinical Studies ( 14 )]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory clinical trials. 1.3 Mixed and Motor Nerve Discontinuity AVANCE is indicated for the treatment of adult and pediatric patients aged one month and older with mixed and motor nerve discontinuity. This indication is approved under accelerated approval based on improvement in s2PD at 12 months in sensory nerve gaps, which provided empirical evidence to reasonably predict clinical benefit given similarities in pathophysiology and anticipated therapeutic effects. [see Clinical Studies ( 14 )]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.