Drugplain

Avance Nerve Graft 4 mm/30mm

Processed nerve allograft · IMPLANT · Axogen Corporation

No Recall History
Plain English

Avance Nerve Graft is a processed nerve implant used to bridge gaps in damaged nerves and help restore nerve function in patients who need nerve repair surgery. It is placed directly into the area of nerve injury to support nerve regeneration.

Key Facts

Brand Name
Avance Nerve Graft
Generic Name
Processed nerve allograft
NDC Code (Product)
84545-430
Manufacturer
Axogen Corporation
Strength
4 mm/30mm
Dosage Form
IMPLANT
Route
SOFT TISSUE
Marketing Status
Application #
BLA125816
Marketing Start
04/06/2026

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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 fo…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • AVANCE is intended for surgical implantation. ( 2.1 ) • The recommended number of AVANCE required is based on the nerve deficits identified for repair. ( 2.1 ) • AVANCE may be trimmed to accommodate the size of the deficits. Each AVANCE is for implantation in a single patient only. ( 2.1 ) • See full prescribing information for AVANCE preparation and administration instructions. ( 2.2 ) ( 2.3 ) 2.1 Recommended Dose AVANCE is intended for surgical implantation. • The recommended number of AVANCE required is based on the nerve deficits identified for repair. • AVANCE may be trimmed to accommodate the size of the deficits. Each AVANCE is intended for implantation in a single patient only. • AVANCE is available in 16 size combinations of different lengths and diameters to fit the size and diameter of the nerve(s) to be treated. Healthcare professionals should carefully assess the length and diameter of the nerve deficit(s) to be treated to determine the most suitable quantity and sizes of AVANCE required for treatment. [see Dosage and Administration ( 2.3 )]. Refer to Table 1 for the available sizes of AVANCE: Table 1. Available Sizes of AVANCE Length (mm)…

Contraindications

4 CONTRAINDICATIONS None. None. ( 4 )

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) Procedu…

Frequently Asked Questions

What is Avance Nerve Graft used for?

Avance Nerve Graft is a processed nerve implant used to bridge gaps in damaged nerves and help restore nerve function in patients who need nerve repair surgery. It is placed directly into the area of nerve injury to support nerve regeneration.

Is Avance Nerve Graft a controlled substance?

Avance Nerve Graft is not classified as a controlled substance by the DEA.

What is the generic name for Avance Nerve Graft?

The generic name for Avance Nerve Graft is Processed nerve allograft. There are no other listed brand versions of Processed nerve allograft.

What is the NDC code for Avance Nerve Graft 4 mm/30mm?

The NDC (National Drug Code) for Avance Nerve Graft 4 mm/30mm is 84545-430, listed by Axogen Corporation.

Product NDC

84545-430

Package NDC

84545-430-01

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