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%， 极端情况，每年损失500万个工作日，费用150美元 临床护理的标准是从神经干细胞中进行自体神经移植。 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 精确地到达切断神经远端的目标。它已经过广泛的测试 在长达3 cm的间隙中，并在短间隙动物中证明了优于现有器械 模型，并在长间隙动物模型中优于自体神经移植物。该项目将投入 制定一项计划，完成临床前研究，向FDA提交IDE申请， 进行可行性临床研究，然后进行510（k）申请。该项目将带来 周围神经损伤、轴突再生、神经病学、神经外科和 生物工程开发一个实用的，具有成本效益的，一致的，跨国相关的 用于治疗周围神经损伤的医疗装置。

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.