Department of Anesthesiology & Pain Medicine, University of California San Diego, San Diego, CA 92037, USA.
Department of Anesthesiology, VA San Diego Healthcare System, San Diego, CA 92161, USA.
Pain Manag. 2021 May;11(3):227-236. doi: 10.2217/pmt-2020-0042. Epub 2020 Dec 9.
The StimRouter peripheral nerve stimulation system created by Bioness, Inc., (CA, USA) is US FDA-approved for the treatment of peripheral mononeuropathy refractory to conservative medical management. StimRouter is a minimally invasive system that utilizes a subcutaneously implanted lead with integrated anchor and electrodes, and an external pulse generator to produce peripheral neuromodulation and achieve pain relief. Multiple published clinical trials reviewed here have shown the StimRouter system to have a high margin of safety, differentiating it from other existing peripheral neuromodulation systems requiring open surgical electrode placement and implantable pulse generators. These studies have also shown the StimRouter system to be efficacious in the treatment of multiple peripheral mononeuropathies; improving patient pain, activity levels and quality of life. StimRouter represents a feasible option for management of chronic peripheral mononeuropathy.
由 Bioness, Inc.(美国加利福尼亚州)制造的 StimRouter 外周神经刺激系统已获得美国食品药品监督管理局批准,用于治疗对保守医疗管理无反应的周围单神经病。StimRouter 是一种微创系统,它使用带有集成固定器和电极的皮下植入导线和外部脉冲发生器来产生周围神经调节,以实现缓解疼痛。本文回顾了多项已发表的临床试验,结果表明 StimRouter 系统具有很高的安全性,与其他需要开放式手术电极放置和可植入脉冲发生器的现有外周神经调节系统区分开来。这些研究还表明,StimRouter 系统在外周单神经病的治疗中是有效的,可改善患者的疼痛、活动水平和生活质量。StimRouter 为慢性周围单神经病的治疗提供了一种可行的选择。