The Neurospan Bridge: A Device for Peripheral Nerve Repair

周围神经损伤(PNI)发生在所有创伤病例的3%和战斗损伤的30%。 每年损失500万个工作日，造成150美元的损失 在美国每年10亿美元。诊所的护理标准是自体神经移植 病人的腿。NeuroSpan Bridge是一种独特的仿生多通道支架， 在整个结构中保持线性，从而加速和引导再生轴突 准确地指向他们被切断的神经远端的目标。它已经经过了广泛的测试 在长达3厘米的缝隙中，并在短缝隙动物中显示出优于现有装置的优势 模型，以及在长间隙动物模型中自体神经移植的优越性。这个项目将投入使用 制定完成临床前研究的计划，向FDA提交IDE申请并进行 进行可行性临床研究，然后应用510(K)。拟议的项目带来了 周围神经损伤、轴突再生、神经病学、神经外科和 生物工程，以开发实用的、经济高效的、一致的和跨国相关的 治疗周围神经损伤的医疗器械。

Peripheral Nerve Injury (PNI) occurs in 3% of all trauma cases and 30% of combat injuries to the extremities, resulting in a loss of five million working days each year and costs of $150 billion annually in the U.S. The standard of care in the clinic is a nerve autograft from the patients’ leg. The NeuroSpan Bridge is a unique, biomimetic, multi-channel scaffold that maintains linearity throughout the structure, thus accelerating and guiding regenerating axons precisely to their targets on the distal end of the transected nerve. It has been extensively tested in gaps up to 3cm-long and demonstrated superiority to existing devices in a short-gap animal model, and superiority to nerve autograft in a long-gap animal model. This project will put in place a program to finalize pre-clinical studies, submit an IDE application to the FDA and carry out a feasibility clinical study followed by 510(k) application. The proposed project brings together experts in peripheral nerve injury, axonal regeneration, neurology, neurosurgery and bioengineering to develop a practical, cost-effective, consistent, and transnationally relevant medical device for the treatment of peripheral nerve injury.