A Study to Confirm the Safety of High Frequency DRG Stimulator in Patients With Chronic Lower Limb Pain

Exclusion Criteria

• •1. Have evidence of a mental or psychological condition that affects pain perception and has difficulty/disability performing objective pain assessment, or have previously failed mental or psychological assessments administered by a psychiatrist that may be deemed to indicate the subject's lack of suitability for participation in this study.
• •2. Subject has exhibited escalating or changing pain condition within the past 30 days as evidenced by Investigator examination.
• •3. Be on anticoagulant medication with INR \>1.5 or platelet count less than 100,000/μL, peripheral vascular diseases (PVDs), visceral pain or uncontrolled Diabetes mellitus (DM).
• •4. Has had corticosteroid therapy at an intended site of stimulation within the past 30 days.
• •5. Pain medication(s) dosages(s) are not stable for at least 30 days.
• •6. Has previously failed spinal cord stimulation therapy.
• •7. Currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump or subject requires magnetic resonance imaging (MRIs) or diathermy.
• •8. Has pain only within a cervical or thoracic distribution.
• •9. Have a current diagnosis of cancer with active symptoms
• •10. Have a known terminal illness with life expectancy less than one year
• •11. Have a systematic or local infection
• •12. Currently has an indwelling device that may pose an increased risk of infection.
• •13. Be pregnant or breast feeding
• •14. Have a medical history of drug or alcohol addiction within the past 2 years.
• •15. Participation in any investigational study in the last 30 days or current enrollment in any trial.
• •16. Be currently involved in an injury claim law suit or medically related litigation, including workers compensation.
• •17. Be a prisoner.