Avance Nerve Graft
Generic: PROCESSED NERVE ALLOGRAFT
Basic Information
Manufacturer
Axogen Corporation
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
SOFT TISSUE
FDA Set ID
e50d90fa-83ef-4d1b-9691-2b9c7bbdc2ae
Indications & Usage
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.
( 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.
Adverse Reactions
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.
( 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.