Subcutaneous Nerve Stimulation for Failed Back Surgery Syndrome (FBSS) Patients

This study is a multi-center, prospective, randomized (1:1) parallel-group design.

Key Inclusion Criteria:

- Have persistent back pain for at least 6 months

- Had back surgery at least 6 months ago

- Have tried pain medications and physical therapy

- Read and understand written English or Spanish

- Male or non-pregnant female. If female of child-bearing potential, and if sexually
active, must be using a medically-acceptable method of birth control during study
participation

- Willing and able to undergo surgical implant procedure, attend visits as scheduled,
and comply with the study requirements

- Have an expected lifespan greater than 12 months

Key Exclusion Criteria:

- Have leg pain in addition to back pain.

- Currently enrolled in or plan to enroll in another drug and/or device study

- Have peripheral vascular disease, peripheral neuropathy, small-fiber neuropathy, or
fibromyalgia

- Have an active systemic infection or are immunocompromised

- Will be exposed to diathermy or anticipate needing a full-body MRI scan

- Currently have an implantable cardiac pacemaker, defibrillator, or neurostimulator

- Treated with spinal cord stimulation, peripheral nerve stimulation, an intrathecal
drug delivery system or requires additional back surgery