Efficacy of the Spinal Cord Stimulation System as Salvage Therapy
Efficacy of the Spinal Cord Stimulation System as Salvage Therapy
The primary objective of this study is to evaluate the efficacy of spinal cord stimulation
 using the Precision implantable neurostimulation device for chronic and intractable pain of
 the trunk and or limbs in patients who have failed treatment with an intraspinal infusion
 pump or other SCS system.
Chronic pain is managed by the sequential application of various strategies: medications,
 anesthetic injections, ablation, surgery, implantable intraspinal infusion pumps, and spinal
 cord stimulation. For a significant number of patients, however, these treatments are
 inadequate or cannot be tolerated. Those patients require another option for pain relief.

 The therapy afforded by spinal cord stimulators is dependent on overlapping paresthesia with
 the painful areas. One of the leading reasons for explant of SCS systems (not including
 device failure or surgical complication) is the complaint of inadequate pain relief due to
 poor coverage of the painful area. Mounting evidence suggests that the clinical efficacy
 afforded by SCS varies with each manufacturer's technology. For instance,
 previously-implanted SCS patients report more complete coverage, better pain relief, and a
 more pleasant sensation associated with the paresthesia of the Precision system. The tight
 lead spacing and current fractionalization achievable with the Precision system may provide
 pain relief after failure with another SCS system.

 This study will assess pain relief with the Precision system for patients with chronic,
 intractable pain who are refractory to treatment with other types of SCS systems and/or
 implantable intraspinal infusion pumps. Because Precision allows unique programming
 combinations not possible with other systems, it is expected that subjects will enjoy
 significant pain relief.
Inclusion Criteria:

 -  Have chronic and intractable neuropathic pain of the trunk and/or limbs of moderate to
 severe intensity and have failed treatment with an intraspinal infusion pump or other
 SCS device. Determination of failure of treatment will be based on subject feedback.
 Subjects with an active intraspinal infusion pump but with inadequate pain control
 will be allowed to participate;

 -  Be 18 years of age or older;

 -  Be an appropriate candidate for the surgical procedures required for this study;

 -  Be willing and able to comply with all study related procedures and visits;

 -  Be capable of reading and understanding patient information materials and giving
 written informed consent.

 Exclusion Criteria:

 -  Have failed immediate past treatment with an intraspinal infusion pump or other SCS
 device because of technical reasons associated with the device such as unresolved lead
 migration, battery depletion, etc.;

 -  Have any evidence of neurologic instability requiring surgery;

 -  Have any significant medical condition that in the opinion of the investigator may
 interfere with the conduct of the study or may adversely affect the subject's safety
 during the study;

 -  Have any other active implantable device with the exception of a intraspinal infusion
 pump for pain medications;

 -  Are pregnant or lactating or planning to become pregnant in the next year;

 -  Have participated in any investigational drug or device trial in the last 4 weeks or
 plan to participate in any other investigational drug or device trial while on this
 study.