FDA approved guidance conduits and wraps for peripheral nerve injury: a review of materials and efficacy.
Several nerve guidance conduits (NGCs) and nerve protectant wraps are approved by the US Food and Drug Administration (FDA) for clinical use in peripheral nerve repair. These devices cover a wide range of natural and synthetic materials, which may or may not be resorbable. This review consolidates the data pertaining to all FDA approved materials into a single reference, which emphasizes material composition alongside pre-clinical and clinical safety and efficacy (where possible). This article also summarizes the key advantages and limitations for each material as noted in the literature (with respect to the indication considered). In this context, this review provides a comprehensive reference for clinicians which may facilitate optimal material/device selection for peripheral nerve repair. For materials scientists, this review highlights predicate devices and evaluation methodologies, offering an insight into current deficiencies associated with state-of-the-art materials and may help direct new technology developments and evaluation methodologies thereof.
Department of Applied Oral Sciences, Dalhousie University, Halifax, NS, B3H 34R2, Canada. sharonkehoe@dal.ca
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D020341:Absorbable Implants; D000818:Animals; D001672:Biocompatible Materials; D024042:Collagen Type I; D006801:Humans; D009416:Nerve Regeneration / Q000502:physiology; D059348:Peripheral Nerve Injuries / Q000601:surgery / Q000628:therapy*; D011100:Polyglycolic Acid; D019651:Plastic Surgery Procedures / Q000295:instrumentation* / Q000379:methods*; D014182:Transplantation, Autologous; D014481:United States; D014486:United States Food and Drug Administration
D001672:Biocompatible Materials; D024042:Collagen Type I; D011100:Polyglycolic Acid