Avance Nerve Graft Processed nerve allograft 2 mm/50mm Implant, 1 pouch
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🩺 Clinical
- Avance Nerve Graft is a processed scaffold made from donated human nerve tissue. The donor cells are removed, but the internal structure — tiny tubes that guide nerve fiber regrowt...
- What exactly is Avance Nerve Graft, and where does it come from?
- Avance is used to bridge gaps in damaged peripheral nerves — the nerves outside the brain and spinal cord. That includes sensory nerves (which carry feeling), as well as mixed and...
- What kinds of nerve injuries is it used for?
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII M4I0D6VV5M
Calcium chloride is a salt compound that acts as a firming agent and source of calcium ions in medications. It's used in formulations to help maintain tablet structure, improve texture, or serve as a buffering agent.
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UNII 660YQ98I10
Potassium chloride is a mineral salt used in medicines as a buffer and to help maintain the proper pH balance and stability of the formulation during storage and use.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII TU7HW0W0QT
A salt derived from lactic acid, sodium lactate acts as a buffer and pH stabilizer in medicines. It helps maintain the product's acidity level and can also serve as a humectant to retain moisture.
4 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Avance Nerve Graft 2 mm/50mmthis 84545-0250-01 | Axogen | 1 pouch | — | — | FDA listed | — |
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⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Dec 3, 2037 |
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 84545-0250-01 You're viewing this | 1 CARTON in 1 BAG (84545-250-01) / 1 POUCH in 1 CARTON / 1 POUCH in 1 POUCH / 1 CONTAINER in 1 POUCH / 1 mm in 1 CONTAINER | 2026-04-06 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and 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 )
1.1Sensory 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.
1.2Sensory 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.
1.3Mixed 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.
⏱️ Dosage and 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 )
2.1Recommended 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) Diameter Range (mm) AVANCE is available in the lengths and diameters as shown in Table 1 . The graft diameter is measured at each end of the graft, and variation along the length can occur in human tissue.
Length Range (mm) 15 1 to 2 15 to 21 15 2 to 3 15 to 21 15 3 to 4 15 to 21 15 4 to 5 15 to 21 30 1 to 2 30 to 36 30 2 to 3 30 to 36 30 3 to 4 30 to 36 30 4 to 5 30 to 36 50 1 to 2 50 to 56 50 2 to 3 50 to 56 50 3 to 4 50 to 56 50 4 to 5 50 to 56 70 1 to 2 70 to 76 70 2 to 3 70 to 76 70 3 to 4 70 to 76 70 4 to 5 70 to 76
2.2Preparation Receipt and Storage of AVANCE: AVANCE is shipped on dry ice in validated insulated shipping containers. AVANCE must remain frozen at ≤-40°C (≤-40°F) and be kept frozen until use. For a complete description of the AVANCE packaging configuration and storage conditions, [ see How Supplied/Storage and Handling ( 16 )] .
AVANCE is to be prepared in an appropriate surgical environment. Supplies: The following supplies are not included but are needed for preparation: • Room temperature sterile normal saline or sterile Lactated Ringer’s solution (LRS). Preparation Instructions: Following standard surgical site preparation for exposure, mobilization, and trimming of the peripheral nerve to be treated, determine the size and/or number of AVANCE that need to be thawed. [see Dosage and Administration ( 2.3 )].
The following instructions are for preparing one AVANCE. Two team members (one sterile field team member and one team member outside the sterile field) are required. If two or more AVANCE are required, prepare them individually.
AVANCE thawing should take approximately 6 minutes. 1. The team member outside the sterile field removes the desired AVANCE from the freezer and transports it to the operating room.
2. The team member outside the sterile field removes the zip top bag and opens and removes the carton. 3.
The team member outside the sterile field peels open the seal of the outer foil-poly pouch and aseptically presents the inner Tyvek ® -poly pouch to the sterile field team member for placement in the sterile field. The sterile field team member aseptically removes the inner Tyvek-poly pouch presented by the team member outside the sterile field from the inside of the outer foil-poly pouch and places it in the sterile field. 4.
In the sterile field, the sterile field team member peels open the inner Tyvek-poly pouch and removes the clamshell tray. 5. The sterile field team member opens the clamshell tray and fills the pre-molded thawing reservoir with room temperature sterile normal saline or sterile LRS ( Figure 1 ).
Do not heat AVANCE or add heated saline or LRS to the graft. Figure 1: Thawing AVANCE with sterile saline or LRS. Figure 1: Thawing AVANCE with sterile saline or LRS.
6. Do not implant a partially or f…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS AVANCE will vary in color from white, off-white, pink, pale pink, and yellow to pale yellow. AVANCE is a sterile, surgical implant and is intended for administration to a single patient. The available sizes of AVANCE are provided in Table 1 .
AVANCE is available in 16 combination sizes with the following dimensions: • Lengths: 15 mm, 30 mm, 50 mm, and 70 mm • Diameters: 1 to 2 mm, 2 to 3 mm, 3 to 4 mm, and 4 to 5 mm AVANCE may vary in color from white, off-white, pink, pale pink, and yellow to pale yellow. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ 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 )
5.1Procedural 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.
5.2Transmission 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.
🤒 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 [email protected] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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).
6.2Postmarketing 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.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no data on the use of AVANCE in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with AVANCE to assess whether it can cause harm to the mother or fetus when administered to a pregnant woman. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
8.2Lactation Risk Summary There is no data on the effect of AVANCE on human milk, the effect on the breastfed infant, or the effect on milk production.
8.4Pediatric Use The safety and effectiveness of AVANCE have been established in pediatric patients aged one month and older. The use of AVANCE in pediatric patients for the treatment of nerve discontinuity was supported by extrapolation of adult data from the RECON Study. [see Clinical Studies ( 14 )].
8.5Geriatric Use There were 8 patients (4%) who were 65 years of age and older in the RECON Study. Clinical studies of AVANCE did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger subjects.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no data on the use of AVANCE in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with AVANCE to assess whether it can cause harm to the mother or fetus when administered to a pregnant woman. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of AVANCE have been established in pediatric patients aged one month and older. The use of AVANCE in pediatric patients for the treatment of nerve discontinuity was supported by extrapolation of adult data from the RECON Study. [see Clinical Studies ( 14 )].
🧓 Geriatric Use ▾
8.5Geriatric Use There were 8 patients (4%) who were 65 years of age and older in the RECON Study. Clinical studies of AVANCE did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger subjects.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action AVANCE is an acellular nerve scaffold intended to restore nerve function in the distal tissue. AVANCE provides structural and biochemical cues for axonal regeneration. The structural cue is provided by the intact endoneurial tubes.
The biochemical cue is provided by the basement membrane proteins of the endoneurial tubes. The basement membrane of the endoneurial tubes includes many proteins, such as collagen, laminin, fibronectin, and proteoglycans. The laminin lining the endoneurial tubes of AVANCE has been shown in in vitro assays and animal studies to be bioactive by supporting Schwann cell migration, axon growth cone interactions, and neurite extension.
Without the specific bioactive laminin composition, the neuroregenerative capacity is hindered. However, the exact mechanism of action is unknown.
12.2Pharmacodynamics The pharmacodynamic effects of AVANCE are not known.
12.3Pharmacokinetics The pharmacokinetic effects of AVANCE are not known.
🧬 Mechanism of Action ▾
12.1Mechanism of Action AVANCE is an acellular nerve scaffold intended to restore nerve function in the distal tissue. AVANCE provides structural and biochemical cues for axonal regeneration. The structural cue is provided by the intact endoneurial tubes.
The biochemical cue is provided by the basement membrane proteins of the endoneurial tubes. The basement membrane of the endoneurial tubes includes many proteins, such as collagen, laminin, fibronectin, and proteoglycans. The laminin lining the endoneurial tubes of AVANCE has been shown in in vitro assays and animal studies to be bioactive by supporting Schwann cell migration, axon growth cone interactions, and neurite extension.
Without the specific bioactive laminin composition, the neuroregenerative capacity is hindered. However, the exact mechanism of action is unknown.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied AVANCE is shipped on dry ice and supplied frozen, as a single, intact graft of varying color from white, off-white, pink, pale pink, and yellow to pale yellow. Do not use if broken or otherwise compromised. AVANCE is sterile packaged.
The immediate container closure system consists of a clamshell (thermoformed tray) within two pouches, a sealed Tyvek-poly pouch within a foil-poly pouch. The foil-poly pouch is the sterile barrier for AVANCE. The immediate container closure system is packaged in a commercial carton, which is sealed with a Carton Seal Tape and placed in a zip top bag for freezer storage protection, see Figure 2 .
Figure 2: AVANCE Packaging. • AVANCE is available in the following lengths and diameters ( Table 4 ): Table 4: Commercially Available Sizes of AVANCE Length (mm) Diameter (mm) NDC Numbers 15 1 to 2 84545-115-01 15 2 to 3 84545-215-01 15 3 to 4 84545-315-01 15 4 to 5 84545-415-01 30 1 to 2 84545-130-01 30 2 to 3 84545-230-01 30 3 to 4 84545-330-01 30 4 to 5 84545-430-01 50 1 to 2 84545-150-01 50 2 to 3 84545-250-01 50 3 to 4 84545-350-01 50 4 to 5 84545-450-01 70 1 to 2 84545-170-01 70 2 to 3 84545-270-01 70 3 to 4 84545-370-01 70 4 to 5 84545-470-01 Figure 2
16.2Storage and Handling • Ensure the shipping container was received by the date indicated on the shipping container label and that sufficient dry ice is present within the shipping container. The amount of dry ice present within the shipping container can be assessed by the overall shipping container weight. The overall shipping container weight should be at least 12.0 lbs. for the 48-hour shipping container, 15.0 lbs. for the 72-hour shipping container, and 21.0 lbs. for the 120-hour shipping container. • Store AVANCE at ≤-40°C (≤-40°F) and keep frozen until use. • Do not use AVANCE if any component of the immediate container closure system or commercial carton has been compromised. • Thaw AVANCE to room temperature without heating using room temperature sterile normal saline or Lactated Ringer’s Solution (LRS).
Do not implant a partially or fully frozen product. Once thawed, it should not be placed back into the freezer. Thawed AVANCE must be implanted or discarded within 12 hours. • Do not use if the lot number on the outer foil-poly pouch does not match the lot number on the outer carton. • Any expired or thawed AVANCE that is not used in a surgical procedure should be destroyed in accordance with local, state, and federal or country regulations for disposal of human tissue.
Contact Axogen Customer Care at 888-296-4361 for any issues with the condition of the packaging or graft, or for further instructions.
16.1How Supplied AVANCE is shipped on dry ice and supplied frozen, as a single, intact graft of varying color from white, off-white, pink, pale pink, and yellow to pale yellow. Do not use if broken or otherwise compromised. AVANCE is sterile packaged.
The immediate container closure system consists of a clamshell (thermoformed tray) within two pouches, a sealed Tyvek-poly pouch within a foil-poly pouch. The foil-poly pouch is the sterile barrier for AVANCE. The immediate container closure system is packaged in a commercial carton, which is sealed with a Carton Seal Tape and placed in a zip top bag for freezer storage protection, see Figure 2 .
Figure 2: AVANCE Packaging. • AVANCE is available in the following lengths and diameters ( Table 4 ): Table 4: Commercially Available Sizes of AVANCE Length (mm) Diameter (mm) NDC Numbers 15 1 to 2 84545-115-01 15 2 to 3 84545-215-01 15 3 to 4 84545-315-01 15 4 to 5 84545-415-01 30 1 to 2 84545-130-01 30 2 to 3 84545-230-01 30 3 to 4 84545-330-01 30 4 to 5 84545-430-01 50 1 to 2 84545-150-01 50 2 to 3 84545-250-01 50 3 to 4 84545-350-01 50 4 to 5 84545-450-01 70 1 to 2 84545-170-01 70 2 to 3 84545-270-01 70 3 to 4 84545-370-01 70 4 to 5 84545-470-01 Figure 2
📦 Storage and Handling ▾
16.2Storage and Handling • Ensure the shipping container was received by the date indicated on the shipping container label and that sufficient dry ice is present within the shipping container. The amount of dry ice present within the shipping container can be assessed by the overall shipping container weight. The overall shipping container weight should be at least 12.0 lbs. for the 48-hour shipping container, 15.0 lbs. for the 72-hour shipping container, and 21.0 lbs. for the 120-hour shipping container. • Store AVANCE at ≤-40°C (≤-40°F) and keep frozen until use. • Do not use AVANCE if any component of the immediate container closure system or commercial carton has been compromised. • Thaw AVANCE to room temperature without heating using room temperature sterile normal saline or Lactated Ringer’s Solution (LRS).
Do not implant a partially or fully frozen product. Once thawed, it should not be placed back into the freezer. Thawed AVANCE must be implanted or discarded within 12 hours. • Do not use if the lot number on the outer foil-poly pouch does not match the lot number on the outer carton. • Any expired or thawed AVANCE that is not used in a surgical procedure should be destroyed in accordance with local, state, and federal or country regulations for disposal of human tissue.
Contact Axogen Customer Care at 888-296-4361 for any issues with the condition of the packaging or graft, or for further instructions.
📋 Description ▾
11 DESCRIPTION AVANCE (acellular nerve allograft-arwx) is a sterile, acellular nerve scaffold derived from human cadaveric peripheral nerve tissue for surgical implantation. The processing method maintains the three-dimensional scaffold of the native peripheral nerve, including the endoneurial tubes, perineurium, epineurium, and microvasculature of the extracellular matrix (ECM). The processing removes cellular and noncellular components, including cells, fat, blood, axonal debris, and glycosaminoglycans.
AVANCE is saturated in Lactated Ringer’s Solution prior to packaging and storage.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Discuss the following with the patient and/or caregivers. • Procedural Complications Inform patients that procedure-related complications such as infection, pain, swelling, bleeding, scarring, neuroma formation, or delayed wound healing may occur after nerve repair surgery using AVANCE. Advise that careful postoperative monitoring is important. [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6 )]. • Transmission of Infectious Diseases Inform patients that AVANCE is made from cadaveric human tissue and, despite donor screening and validated processing steps, the risk of transmitting infectious diseases cannot be completely eliminated. [see Warnings and Precautions ( 5.2 )] . • Advise the patient to closely follow the physician-prescribed rehabilitation program.