Comparison of Senza to Commercial Spinal Cord Stimulation for the Treatment of Chronic Pain

Inclusion Criteria:

- Have been diagnosed with chronic, intractable pain of the trunk and/or limbs (VAS ≥
5) which has been refractory to conservative therapy for a minimum of 3 months.

- Be an appropriate candidate for the surgical procedures required in this study based
on the clinical judgment of the implanting physician

- Be 18 years of age or older at the time of enrollment

- Be willing and capable of giving informed consent

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

Exclusion Criteria:

- Have a medical condition or pain in other area(s), not intended to be treated with
SCS, that could interfere with study procedures, accurate pain reporting, and/or
confound evaluation of study endpoints, as determined by the Investigator

- Have evidence of an active disruptive psychological or psychiatric disorder or other
known condition significant enough to impact perception of pain, compliance of
intervention and/or ability to evaluate treatment outcome, as determined by a
psychologist

- Have a current diagnosis of a coagulation disorder, bleeding diathesis, progressive
peripheral vascular disease or uncontrolled diabetes mellitus

- Have a diagnosis of scoliosis that precludes lead placement

- Have an existing drug pump and/or SCS system or another active implantable device
such as a pacemaker

- Have prior experience with SCS

- Have a condition currently requiring or likely to require the use of MRI or diathermy

- Have metastatic malignant disease or active local malignant disease

- Have a life expectancy of less than 1 year

- Have an active systemic or local infection

- Be pregnant (if female and sexually active, subject must be using a reliable form of
birth control, be surgically sterile or be at least 2 years post-menopausal)

- Have within 6 months of enrollment a significant untreated addiction to dependency
producing medications or have been a substance abuser (including alcohol and illicit
drugs)

- Be concomitantly participating in another clinical study

- Be involved in an injury claim under current litigation

- Have a pending or approved worker's compensation claim