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 RemoteManagement

• 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 bothoverall pain intensity and pain intensity in the index area of pain, assessed at thetime of enrollment

• Willing and able to comply with all study requirements, including all requiredprocedures, 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 baselineevaluation

• 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 mostrecent result ≤ 8.0%

Exclusion Criteria:

• Any contraindication for SCS therapy

• Patients with an implanted pacemaker, defibrillator, or any other medicalcontraindication for SCS therapy

• Currently implanted with an infusion pump or any implantable neurostimulator device

• Previously implanted with a neurostimulation system or prior participation in atrial period for a neurostimulation system

• Currently enrolled in any investigational device or drug trial for the management ofchronic pain

• Patients who have undergone spinal surgery within 12 months prior to enrollment

• Patients currently involved in an active WorkCover insurance claim and/or activelitigation related to injury associated with indication for SCS

• Patients with a documented history of substance abuse (narcotics, alcohol, etc.) orsubstance 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 becomepregnant 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 betreated with SCS, that could interfere with study procedures, accurate painreporting, and/or confound evaluation of study endpoints, as determined by theinvestigator

• Patients with pain originating from peripheral vascular disease

• Current diagnosis of a coagulation disorder or bleeding diathesis

• Patients with a diagnosis of severe thoracic scoliosis that is likely to precludeSCS lead placement

• Patients who are immunocompromised and/or at high risk for infection

• Patients with a documented history of allergic response or sensitivity tomaterial(s) required for the study (e.g. adhesives, titanium, silicone, etc.)

At the conclusion of the trial period, the absence of the following exclusion criteria should be confirmed before proceeding with the permanent Prospera SCS System implant:

• Reduction in overall pain of less than 50% from baseline, assessed using VAS

• Unsuccessful trial period as otherwise determined by the investigator

• Determined by the investigator to be a poor candidate for permanent Prospera SCSSystem implant per standard of care (e.g. due to infection, non-compliance with painmedication regimen, paresis, clumsiness, numbness, and other)

Additionally, pre-operative screening for staphylococcus aureus (MRSA/MSSA) must be conducted after the SCS trial period and prior to implantation of the permanent device.