Stimgenics Open-Label, Post Market Study

This is an open-label prospective, randomized, controlled, multi-center study comparing Stimgenics Spinal Cord Stimulation (SGX-SCS) programming approach to Standard SCS programming approach.

Subjects meeting study entrance criteria will be randomized in a 1:1 ratio to one of two study treatment groups:

• Test treatment group with SGX-SCS programming approach
• Control treatment group with Standard SCS programming approach

Data at follow-up visits will be compared between the two treatment groups, and in reference to baseline assessments collected at the beginning of the study.

Inclusion criteria

• Be a candidate for SCS system (trial and implant) per labeled indication (back and leg pain)
• Has an average back pain intensity ≥ 5.0 cm on the 10.0 cm Visual Analog Scale (VAS) at the time of enrollment with moderate to severe chronic leg pain
• Be willing and capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the subject's participation has been provided.
• Be willing and capable of subjective evaluation, read and understand English-written questionnaires, and read, understand and sign the written inform consent in English.
• Be 18 years of age or older at the time of enrollment
• Be on a stable pain medication regime, as determined by the study investigator, for at least 30 days prior to enrolling in this study
• Be willing to not increase pain medications from baseline through the 3-Month Visit
• Be willing and able to comply with study-related requirements, procedures, and visits

Exclusion criteria

• Has a medical, anatomical, and/or psychosocial condition that is contraindicated for commercially available IntellisTM SCS systems as determined by the Investigator
• Be concurrently participating in another clinical study
• Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator, and/or drug delivery pump, etc.
• Has pain in other area(s) and/or medical condition requiring the regular use of significant pain medications that could interfere with accurate pain reporting, study procedures, and/or confound evaluation of study endpoints, as determined by the Investigator
• Has mechanical spine instability as determined by the Investigator