This Registry study will prospectively evaluate the long-term effectiveness, safety, and tolerability of the StimRouter Neuromodulation System, along with evaluating the technical performance of StimRouter, surgical outcomes, health-related quality of life, concomitant medical use, and subject's impression of improvement.
A Prospective, Open-label, Long-term, Multi-center, Registry to Assess the Safety and Efficacy of the Bioness StimRouter Neuromodulation System in Subjects With Chronic Pain of Peripheral Nerve Origin
This is a prospective, open-label, long-term, multi-center registry. Up to 1000 subjects with chronic pain related to peripheral nerve will be enrolled by approximately 30 qualified sites. Subjects who are eligible for a StimRouter will be enrolled in order to evaluate the subject's experience at pre-implant, the implant, and post-implant for up to 60 months. Based on routine care, subjects will be seen at day of implant, within 2 weeks post-implant, 1 month post-implant, 3 months post-implant, 6 months post-implant, 12 months post-implant, and annually thereafter for the duration of the study. Specific assessments will be completed by the subject and clinician at these visits.