FDA
FDA approves nerve scaffold for sensory nerve discontinuity treatment
FDA approved Avance (acellular nerve allograft-arwx) for surgical implantation to repair sensory nerve discontinuities ≤25 mm in adults and pediatric patients ≥1 month of age. Through the Accelerated Approval pathway, Avance is also indicated for larger sensory gaps and motor or mixed nerve injuries. In trials, Avance showed statistical non-inferiority to collagen nerve cuffs for return of sensory function.
Avance is processed from cadaveric nerve tissue to preserve its natural structure, eliminating the need for autograft harvest. Common adverse reactions include procedural pain and hyperesthesia. Patients should be monitored for infection, implant site swelling, adhesions, impaired function, and neuroma formation. As a human tissue product, Avance may carry a theoretical risk of infection, though no cases have been reported. FDA approval was granted to Axogen Corporation, with confirmatory trials required.
Source:
(2025, December 3). FDA. FDA Approves Nerve Scaffold for the Treatment of Sensory Nerve Discontinuity https://www.fda.gov/news-events/press-announcements/fda-approves-nerve-scaffold-treatment-sensory-nerve-discontinuity