The U.S. Food and Drug Administration (FDA) has approved Avance (acellular nerve allograft-arwx), marking a significant advancement in the treatment of sensory nerve discontinuities. This decision, announced on December 4, 2025, provides new options for adult and pediatric patients aged one month and older with discontinuities of up to 25 millimeters. Avance is also approved, under the Accelerated Approval pathway, for larger gaps, motor nerve injuries, and mixed nerve discontinuities.
What changed?
The FDA’s approval of Avance introduces a new peripheral nerve scaffold for patients with nerve damage. Unlike traditional autografts, which require harvesting healthy nerve tissue from the patient, Avance is derived from donor tissue (cadavers) that is processed to remove cellular components while retaining the nerve’s natural scaffolding. This eliminates the need for an additional surgical site and offers a potentially easier recovery for patients.
Avance is now available for sensory nerve repairs of ≤25mm gaps, with approval extended to larger discontinuities and motor or mixed nerve injuries under the Accelerated Approval pathway. The approval aims to address an unmet need in peripheral nerve care.
What clinical evidence supports Avance?
Clinical evaluations of Avance demonstrated its efficacy in treating sensory nerve discontinuities. The pivotal study measured the return of sensory function as a primary endpoint, comparing Avance to collagen nerve cuffs. The results showed that Avance achieved statistical non-inferiority to this comparator. Additionally, Avance was investigated in cases involving motor and mixed nerve injuries, further highlighting its potential application in various nerve repair scenarios.
The FDA’s decision to grant approval under the Accelerated Approval pathway requires Axogen Corporation, the manufacturer, to conduct confirmatory clinical trials to verify clinical outcomes for broader applications. These findings underscore the device’s value in nerve function restoration while ensuring further evidence is gathered to support its expanded use.
What safety considerations should clinicians be aware of?
The most frequently reported adverse events from clinical trials of Avance included procedural pain and heightened sensitivity to stimuli such as touch and temperature (hyperesthesia). Other potential complications include:
- Infection
- Swelling at the implant site
- Adhesion or scar formation
- Impaired motor or sensory function
- Bleeding and neuroma formation
Because Avance is derived from human cadaveric tissue, it carries a theoretical risk of transmitting infectious agents. However, no incidents of such transmissions have been identified to date. Health professionals are encouraged to monitor patients for any adverse effects and report any suspected infections related to the device to the manufacturer, Axogen Corporation.
FAQ
- Who can benefit from Avance?
Avance is intended for adults and pediatric patients aged one month and older with sensory nerve gaps of ≤25mm, and through additional approval, for larger discontinuities and motor or mixed nerve injuries. - What differentiates Avance from traditional treatment?
Unlike autografts that require harvesting the patient’s own nerve tissue, Avance is derived from donor tissue. This eliminates the need for additional surgery to obtain nerve grafts. - What are the main safety concerns?
The most common issues are procedural pain, hyperesthesia, and potential infection risks. Clinicians should monitor patients and report any device-related complications.
Conclusion
The FDA’s approval of Avance represents a meaningful step forward for the treatment of sensory, motor, and mixed nerve injuries. The device offers significant benefits in terms of eliminating the need for additional surgery while supporting nerve function recovery. As Axogen conducts confirmatory trials, healthcare providers are advised to stay updated on continued data supporting Avance’s clinical benefits and extended uses.
Disclaimer
This article is intended for informational purposes and does not constitute legal or regulatory advice. Healthcare professionals should consult appropriate regulatory guidance for decision-making.
FDA Announcement
For full information about the FDA announcement, see the link below.
https://www.fda.gov/news-events/press-announcements/fda-approves-nerve-scaffold-treatment-sensory-nerve-discontinuity