A Review of the StimRouter^® Peripheral Neuromodulation System for Chronic Pain Management

Abstract

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.

Keywords::

• Bioness
• chronic pain
• mononeuropathy
• neuromodulation
• neuropathic pain
• pain
• peripheral nerve stimulation
• peripheral nerve stimulator
• peripheral neuromodulation
• StimRouter^®

Financial & competing interests disclosure

KV Chakravarthy is a consultant to Abbott, Bioness, Boston Scientific, Medtronic, Saluda Medical, Medincell, Omnia Medical, PAINTeq and SPR Therapeutics. He has stock options in Higgs Boson Health, Nalu Medical, Mainstay Medical, Aya Biosciences, and Oska Wellness. He is founder of Douleur Therapeutics, Stimlock, NXTStim, and Newrom Biomedical. RA Gabriel’s institution has received funding and/or product for his research from Ferrosan Medical Devices, Myoscience, Epimed, SPR Therapeutics and InfuTronix. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Company review disclosure

In addition to the peer-review process, with the author’s consent, the manufacturer of the product discussed in this article was given the opportunity to review the manuscript for factual accuracy. Changes were made by the author at their discretion and based on scientific or editorial merit only. The author maintained full control over the manuscript, including content, wording and conclusions.

Additional information

Funding

KV Chakravarthy is a consultant to Abbott, Bioness, Boston Scientific, Medtronic, Saluda Medical, Medincell, Omnia Medical, PAINTeq and SPR Therapeutics. He has stock options in Higgs Boson Health, Nalu Medical, Mainstay Medical, Aya Biosciences, and Oska Wellness. He is founder of Douleur Therapeutics, Stimlock, NXTStim, and Newrom Biomedical. RA Gabriel’s institution has received funding and/or product for his research from Ferrosan Medical Devices, Myoscience, Epimed, SPR Therapeutics and InfuTronix. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.No writing assistance was utilized in the production of this manuscript.