BurstDR Stimulation for Painful Diabetic Neuropathy

Inclusion Criteria:

• Diagnosis of lower extremity Painful Diabetic Neuropathy (PDN) with symptoms for atleast a year prior to signing the consent form

• PDN refractory to FDA approved medications: duloxetine, pregabalin, tapentadol, andcapscaicin

• 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 basedon the clinical judgment of the implanting physician

• Be capable of subjective evaluation, able to read and understand English-writtenquestionnaires, and able to read, understand and sign the written informed consentin English

• Be willing and capable of giving informed consent

• Be willing and able to comply with study-related requirements, procedures, andscheduled visits

• Have adequate cognitive ability to use a patient programmer and recharger asdetermined by the Investigator

• Be on a stable analgesic regimen, as determined by the Investigator, for at least 30days prior to assessing pain intensity, and be willing to stay on those medicationswith no dose adjustments until activation of the permanently implanted SCS device

• Have stable neurological status measured by motor, sensory and reflex function asdetermined by the investigator

Exclusion Criteria:

• Current daily opioid dosage greater than 120 mg morphine equivalents

• Have an average pain intensity of ≥ 3 out of 10 cm on the VAS in the upperextremities due to diabetic neuropathy at enrollment

• Have a diagnosis of a lower limb mononeuropathy (e.g., causalgia and tibial orperoneal neuropathies), have had a lower limb amputation other than toes due todiabetes, or have large (≥3 cm) and/or gangrenous ulcers of the lower limbs.

• Have a current diagnosis of a progressive neurological disease such as multiplesclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressivearachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, ComplexRegional Pain Syndrome, acute herniating disc, severe spinal stenosis and brachialplexus injury, as determined by the Investigator

• Have a current diagnosis or condition such as a coagulation disorder, bleedingdiathesis, platelet dysfunction, low platelet count, severely diminished functionalcapacity due to underlying cardiac/pulmonary disease, symptomatic uncontrolledhypertension, progressive peripheral vascular disease or uncontrolled diabetesmellitus that presents excess risk for performing the procedure, as determinedclinically by the Investigator

• Be benefitting from an interventional procedure and/or surgery to treat lower limbpain (Subjects should be enrolled at least 30 days from last benefit).

• Have an existing intrathecal pain pump and/or another active implantable device suchas a pacemaker

• Have a condition currently requiring or likely to require the use of diathermy orMRI that is inconsistent with ProclaimTM system guidelines in the Physician's Manual

• Have either a metastatic malignant neoplasm or untreated local malignant neoplasm

• Have a life expectancy of less than one year

• Have within 6 months of enrollment a significant untreated addiction to dependencyproducing medications, alcohol or illicit drugs

• Be concomitantly participating in another clinical study

• Be involved in an injury claim under current litigation

• Be a recipient of temporary Social Security Disability Insurance (SSDI) benefits dueto chronic pain

• Have a pending or approved worker's compensation claim

• Have evidence of an active disruptive psychological or psychiatric disorder or otherknown condition significant enough to impact perception of pain, compliance withintervention and/or ability to evaluate treatment outcome, as determined by apsychologist in the last 12 months