SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery

Key Inclusion Criteria:

• Chronic low back pain, with or without leg pain, for at least 6 months

• Received at least 90 days of documented pain management care to address the primarypain complaint, prior to Screening (e.g. medication, physical therapy)

• If female of childbearing potential: not pregnant, as evidenced by a negativepregnancy test at Screening

• Subject signed a valid, IRB-approved informed consent form (ICF) provided in English

Key Exclusion Criteria:

• Primary pain complaint of vascular origin (e.g. peripheral vascular disease)

• Require implantation of lead(s) in the cervical epidural space

• Significant cognitive impairment at Screening that, in the opinion of theInvestigator, would reasonably be expected to impair the study candidate's abilityto assess pain intensity

• Previous failed spinal cord stimulation trial or is already implanted with an activeimplantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)