BurstDR Stimulation for Painful Diabetic Neuropathy

Inclusion Criteria: * Diagnosis of lower extremity Painful Diabetic Neuropathy (PDN) with symptoms for at least a year prior to signing the consent form * PDN refractory to FDA approved medications: duloxetine, pregabalin, tapentadol, and capscaicin * Lower limb pain intensity of 5 cm or more on a 10-cm visual analogue scale (VAS) * HbA1c ≤10% * BMI \<45 kg/m2 * Be 22 years of age or older at the time of enrollment * Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician * Be capable of subjective evaluation, able to read and understand English-written questionnaires, and able to read, understand and sign the written informed consent in English * Be willing and capable of giving informed consent * Be willing and able to comply with study-related requirements, procedures, and scheduled visits * Have adequate cognitive ability to use a patient programmer and recharger as determined by the Investigator * Be on a stable analgesic regimen, as determined by the Investigator, for at least 30 days prior to assessing pain intensity, and be willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device * Have stable neurological status measured by motor, sensory and reflex function as determined by the investigator Exclusion Criteria: * Current daily opioid dosage greater than 120 mg morphine equivalents * Have an average pain intensity of ≥ 3 ou…