Clinical Study of a Micro-Implantable Pulse Generator for the Treatment of Peripheral Neuropathic Pain (COMFORT 2)

Exclusion Criteria

• •Subject currently has an active implantable medical device such as a drug pump, spinal cord stimulator, peripheral nerve stimulator, sacral nerve stimulator, deep brain stimulator, and/or cardiac pacemaker.
• •2\. Subject has previously failed PNS or Spinal Cord Stimulation (SCS) or Dorsal Root Ganglion (DRG) therapy (trial or permanent implant). See note below.
• •3\. Pain is completely absent at rest. 4. Patient has clinical evidence of complex regional pain syndrome (CRPS), peripheral neuralgia of metabolic origin, post-herpetic neuralgia, biochemical evidence of a metabolic or genetic neuropathy (e.g., Charcot'- Marie- Tooth Disease) or mixed motor/sensory polyneuropathy.
• •5\. Subject has a medical condition that would prevent them from participating in the current study per investigator's or medical monitor's judgment.
• •6\. Subject has had a successful (≥ 50% pain relief) interventional procedure within the past 3 months to treat the same pain condition(s) being examined in this study including, nerve blocks.
• •7\. Uncontrolled depression or uncontrolled psychiatric disorders 8. Subject is currently participating in another clinical investigation with an active treatment arm.
• •9\. Subject is allergic or sensitive to materials used in the device components including, skin adhesives or does not tolerate the wearable aspect of the device.
• •10\. Subject has pending or ongoing legal issues (including unresolved worker's compensation claims or equivalent) or other conflicting secondary gain issues related to their chronic pain condition.
• •11\. Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, or progressive peripheral vascular disease that has not been medically corrected.
• •12\. Subject has an active systemic infection. 13. Subject is unable to read and/or write in English or give informed consent. 14. Subject has a life expectancy of less than 1 year. 15. Subject has an active malignant neoplasm (metastatic or local) or evidence of paraneoplastic syndrome.
• •16\. Subject with uncontrolled diabetes mellitus, showing signs of diabetic neuropathy, as evidenced by a neurological exam and a HbA1c test.
• •17\. Subject has evidence of an alcohol or drug dependency within the last 6 months prior to enrollment.
• •18\. Subject is pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 1 year post-menopausal).
• •19\. Subject is nursing/breastfeeding. 20. Subject is on ≥90 mg-morphine equivalents per 24 hours. 21. Subject has undergone an ablative treatment of the target peripheral nerve, or proximal nerve trunk giving rise to the target nerve, or dorsal roots (and DRGs) that ultimately make up the target nerve. No ablative procedures directed at the spinal cord, dorsal roots, or peripheral nerve(s) being treated in the study. To note, subjects who have undergone RF ablation of the dorsal rami, cool pulsed RF of the facet innervation may be considered for enrollment.