Processed Nerve Allograft
Processed nerve allograft (Avance Nerve Graft) is a surgically implanted nerve scaffold used to treat sensory, mixed, and motor nerve discontinuity — gaps in damaged nerves — in adults and children as young as one month old.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Processed Nerve Allograft: Patient Information Guide
A plain-language walkthrough of Processed Nerve Allograft — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Avance Nerve Graft is a processed nerve scaffold implanted surgically to repair gaps in damaged nerves. It is approved for use in adults and children as young as one month old.
- Avance Nerve Graft: Sensory nerve discontinuity with gaps of 25 mm or shorter
- Avance Nerve Graft: Sensory nerve discontinuity with gaps longer than 25 mm — approved under accelerated approval; continued approval may depend on confirmatory trials
- Avance Nerve Graft: Mixed and motor nerve discontinuity — approved under accelerated approval; continued approval may depend on confirmatory trials
⚙️How it works▾
Avance Nerve Graft works as a bridge across a damaged nerve gap. Its preserved internal structure — tiny channels called endoneurial tubes — gives growing nerve fibers a physical path to follow. The inner walls of these channels are lined with proteins (including laminin, collagen, and fibronectin) that send biological signals encouraging nerve cell migration, nerve fiber growth cone interaction, and new nerve fiber extension (neurite outgrowth). The exact mechanism is not fully known, but the bioactive laminin in particular appears important for supporting nerve regeneration.
💊How it's taken▾
Avance Nerve Graft is surgically implanted — it is not taken by mouth or applied at home. The number and size of grafts used depend on the size and number of nerve gaps being repaired, as determined by the surgeon. Each graft is a one-time implant for a single patient.
- The graft is thawed in sterile saline or Lactated Ringer's solution for about 6 minutes just before implantation — never heated
- Once thawed, the graft must be implanted or discarded within 12 hours
- The graft may be trimmed to fit the nerve defect precisely
🤒Side effects — in detail▾
The most common side effects reported with Avance Nerve Graft in clinical studies were mild to moderate and related to the surgical procedure.
- Procedural pain (reported in 4% of patients)
- Hyperesthesia — heightened or uncomfortable skin sensitivity — at the implant site (3%)
- Infection at the implant site
- Swelling at the implant site
- Adhesions (internal scar tissue bands)
- Hypertrophic (thickened, raised) scarring
- Impaired motor or sensory function
- Neuroma formation (an overgrowth of nerve tissue)
One serious adverse reaction (wound dehiscence — the surgical wound reopening) occurred in a clinical trial. Contact your surgical team right away if your wound opens, you develop signs of infection, or you notice worsening pain or loss of sensation or movement.
⚠️Warnings & precautions▾
- Risk of infectious disease transmission: Avance Nerve Graft is made from human donor tissue. Although donors are screened and tested for HIV, hepatitis B and C, syphilis, HTLV-1, and HTLV-2, and screened for CJD, no screening process eliminates all risk. No confirmed cases of viral disease or CJD transmission from Avance have ever been reported. Any suspected infection should be reported to Axogen Corporation at 1-888-296-4361.
- Procedural complications: Surgery to implant the graft carries risks including pain, heightened sensitivity, infection, swelling, internal scarring, thickened scars, bleeding, impaired nerve function, and neuroma formation. Anesthesia-related risks also apply. Your surgical team will monitor for these and manage them if they occur.
📋Before taking it▾
- Pregnancy: There is no safety data for Avance Nerve Graft use during pregnancy. No animal reproductive studies have been done. Discuss the risks and benefits with your doctor.
- Breastfeeding: There is no data on effects on breast milk, the nursing infant, or milk production. Talk to your doctor before proceeding.
- Children: Avance Nerve Graft is approved for pediatric patients aged one month and older. Pediatric use is based on extrapolation from adult clinical data.
- Older adults (65+): Only a small number of patients 65 and older participated in clinical studies. It is not known whether they respond differently from younger patients.
- Because the graft is derived from human donor tissue, patients should be aware of the small but real risk of infectious disease transmission before consenting to surgery.
📦How to store it▾
Store AVANCE at ≤-40°C (≤-40°F) and keep frozen until use.
📄 Written from Processed Nerve Allograft’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Processed Nerve Allograft — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Avance Nerve Graft, and where does it come from? ▾
What kinds of nerve injuries is it used for? ▾
What side effects should I watch for after the procedure? ▾
Is there any risk from the graft being made from human tissue? ▾
Can Avance Nerve Graft be used if I'm pregnant or breastfeeding? ▾
How will I know if the nerve graft is working? ▾
Is Processed Nerve Allograft available over the counter? ▾
When was Processed Nerve Allograft first available? ▾
Who makes Processed Nerve Allograft? ▾
💬 Answers drafted from Processed Nerve Allograft’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Processed Nerve Allograft comes
Processed Nerve Allograft is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Insert or device
How this form is used
- Avance Nerve Graft is used to repair sensory nerve gaps of 25 mm or shorter in adults and children aged one month and older
- Avance Nerve Graft is used to repair sensory nerve gaps longer than 25 mm in adults and children aged one month and older (accelerated approval)
- Avance Nerve Graft is used to repair mixed and motor nerve discontinuity in adults and children aged one month and older (accelerated approval)
- Avance Nerve Graft is thawed in sterile normal saline or Lactated Ringer's solution for approximately 6 minutes immediately before surgical use — it must not be heated
- Avance Nerve Graft must be implanted or discarded within 12 hours of thawing
- Avance Nerve Graft is available in 16 size combinations; the surgeon selects the length and diameter that best matches the nerve gap to be repaired
- Avance Nerve Graft may be trimmed to fit the defect, and each graft is intended for a single patient only
Show 10 more strengths Show fewer strengths
📊 Processed Nerve Allograft across the U.S. market
How Processed Nerve Allograft appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 Compare Processed Nerve Allograft products
A representative set of FDA-listed product records for Processed Nerve Allograft — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Insert or device | ||||
| HUMAN PERIPHERAL NERVE TISSUE 1 mm/15mm | Soft Tissue | Axogen Corporation | BLA | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 1 mm/30mm | Soft Tissue | Axogen Corporation | BLA | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 1 mm/50mm | Soft Tissue | Axogen Corporation | BLA | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 1 mm/70mm | Soft Tissue | Axogen Corporation | BLA | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 2 mm/15mm | Soft Tissue | Axogen Corporation | BLA | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 2 mm/30mm | Soft Tissue | Axogen Corporation | BLA | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 2 mm/50mm | Soft Tissue | Axogen Corporation | BLA | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 2 mm/70mm | Soft Tissue | Axogen Corporation | BLA | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 3 mm/15mm | Soft Tissue | Axogen Corporation | BLA | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 3 mm/30mm | Soft Tissue | Axogen Corporation | BLA | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 3 mm/50mm | Soft Tissue | Axogen Corporation | BLA | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 3 mm/70mm | Soft Tissue | Axogen Corporation | BLA | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 4 mm/15mm | Soft Tissue | Axogen Corporation | BLA | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 4 mm/30mm | Soft Tissue | Axogen Corporation | BLA | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 4 mm/50mm | Soft Tissue | Axogen Corporation | BLA | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 4 mm/70mm | Soft Tissue | Axogen Corporation | BLA | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 1 mm/15mm | — | Isomedix Operations Inc | DRUG FOR FURTHER PROCESSING | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 1 mm/30mm | — | Isomedix Operations Inc | DRUG FOR FURTHER PROCESSING | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 1 mm/50mm | — | Isomedix Operations Inc | DRUG FOR FURTHER PROCESSING | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 1 mm/70mm | — | Isomedix Operations Inc | DRUG FOR FURTHER PROCESSING | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 2 mm/15mm | — | Isomedix Operations Inc | DRUG FOR FURTHER PROCESSING | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 2 mm/30mm | — | Isomedix Operations Inc | DRUG FOR FURTHER PROCESSING | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 2 mm/50mm | — | Isomedix Operations Inc | DRUG FOR FURTHER PROCESSING | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 2 mm/70mm | — | Isomedix Operations Inc | DRUG FOR FURTHER PROCESSING | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 3 mm/15mm | — | Isomedix Operations Inc | DRUG FOR FURTHER PROCESSING | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 3 mm/30mm | — | Isomedix Operations Inc | DRUG FOR FURTHER PROCESSING | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 3 mm/50mm | — | Isomedix Operations Inc | DRUG FOR FURTHER PROCESSING | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 3 mm/70mm | — | Isomedix Operations Inc | DRUG FOR FURTHER PROCESSING | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 4 mm/15mm | — | Isomedix Operations Inc | DRUG FOR FURTHER PROCESSING | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 4 mm/30mm | — | Isomedix Operations Inc | DRUG FOR FURTHER PROCESSING | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 4 mm/50mm | — | Isomedix Operations Inc | DRUG FOR FURTHER PROCESSING | View NDC → |
| HUMAN PERIPHERAL NERVE TISSUE 4 mm/70mm | — | Isomedix Operations Inc | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 32 of 32 products — FDA National Drug Code Directory. See every product, package size and price: browse all 32 Processed Nerve Allograft NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Processed Nerve Allograft — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Processed Nerve Allograft in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Processed Nerve Allograft went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
📦 Supply & shortage status
Whether Processed Nerve Allograft is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
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🏭 Manufacturers & labelers
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Axogen Corporation is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.