Safety and Effectiveness Study of the Precision SCS Systems Adapted for High-Rate Spinal Cord Stimulation

To evaluate the safety and effectiveness of high rate spinal cord stimulation (HR-SCS)
therapy as an aid in the management of chronic intractable pain of the trunk using the Boston
Scientific (BSC) PRECISION Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord
Stimulation

Inclusion Criteria:

- Have been diagnosed with chronic, intractable pain of the trunk (NRS ≥ 5) which has
been refractory to conservative therapy for a minimum of 90 days.

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

- Be 22 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 previous spinal cord stimulation trial or is already implanted with an active
implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)

- Have a current systemic infection, or local infection in close proximity to
anticipated surgical field

- Pregnant or plan to get pregnant during the course of the study or not using adequate
contraception.

- Be participating in another clinical study that may influence the data collected for
the study