Injectable spinal cord stimulator system: Pilot study

Abstract

Spinal cord stimulation (SCS) is widely used for relief of chronic back and limb pain. However, numerous adverse events pose a hindrance to the widened acceptability of the treatment. A prospective, nonrandomized cohort study was conducted to compare the efficacy of a wirelessly powered SCS novel system with commercial SCS systems. Each of 12 patients were serially implanted with a Medtronic 1 × 8 SCS trial lead and a Stimwave Freedom trial lead for a 1-day evaluation. Patients were asked to report on pain relief, paresthesia coverage, paresthesia intensity, and paresthesia comfort. Ten of the 12 patients successfully underwent the trial whereas the remaining 2 procedures were terminated because of operating-equipment failures. Of the successful patients, all reported good pain relief and paresthesia for each device. The average pain reduction was reported as 80% for the Stimwave system and 66% for the Medtronic system. The average paresthesia coverage was 91% and 77%, respectfully. Differences in the averages reported by patients can be attributed to the fact that no randomization was designed in the study. The study showed that wirelessly powered, injectable SCS systems are just as effective as commercial products at relieving pain and at creating paresthesia coverage for patients who suffer from chronic back and limb pain and have the added advantages of shortened procedure time and elimination of open ports during the trial periods, as well as elimination of the need for tunneling and pocket creation for implantable pulse generators.