A First in Human Feasibility Study to Evaluate the Safety and Effectiveness of the BIOTRONIK Prospera SCS System with HomeStream Remote Management

Inclusion Criteria: * Currently indicated for SCS therapy for the treatment of low back and/or leg pain * Planned permanent implant of BIOTRONIK's Prospera SCS System with HomeStream Remote Management * Planned placement of two BIOTRONIK Resilience SCS trial leads * Documented scores of ≥ 60 mm out of 100 mm on the Visual Analog Scale (VAS) for both overall pain intensity and pain intensity in the index area of pain, assessed at the time of enrollment * Willing and able to comply with all study requirements, including all required procedures, phone and/or video calls, and study visits * Age greater than or equal to 18 years and less than 80 years * Able to understand the nature of the study and provide written informed consent * Able to read, understand, and speak English * Patient's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation * Oswestry Disability Index (ODI) score of 41 to 80 out of 100 * Passed psychological evaluation * For diabetic patients: minimum of one HbA1c test within the last 6 months, with most recent result ≤ 8.0% Exclusion Criteria: * Any contraindication for SCS therapy * Patients with an implanted pacemaker, defibrillator, or any other medical contraindication for SCS therapy * Currently implanted with an infusion pump or any implantable neurostimulator device * Previously implanted with a neurostimulation system or prior participation in a trial period for a neurostimulation system * Currently enrolled in any investigational device or drug trial for the management of chronic pain * Patients who have undergone spinal surgery within 12 months prior to enrollment * Patients currently involved in an active WorkCover insurance claim and/or active litigation related to injury associated with indication for SCS * Patients with a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency (other than prescribed) in the 6 months prior to enrollment * Patients currently displaying opioid-seeking behavior * Presence of any life-threatening, underlying illness * Life expectancy less than 1 year * Patients reporting pregnancy at the time of enrollment or intending to become pregnant during the 2-year study duration * Patients with opioid dosages \> 120 morphine milligram equivalents (MME) per day * Patients with poor compliance for pain management regimen * Patients with a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study …