Boston Scientific Precision - Page 11

Indications for Use
Clinician Manual
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References
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Chronic Back and Extremity Pain.” Spine, 21:2786-2793, 1996.
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back and leg pain”. Acta Neurochirgica, 64:109-115, 1995.
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Subperception Therapy – Clinical Summary
Determination of the safety and effectiveness of the Boston Scientic Spinal Cord Stimulator (SCS) Systems
for subperception therapy was based on a prospective, randomized, multicenter, crossover study with the
primary endpoint of responder rate (proportion of subjects with 50% or greater improvement in overall pain) at
3 month post-device activation. A crossover design provided a within-subject comparison between the supra-
perception and subperception settings.
The primary objective of this study was to demonstrate sustained clinically signicant pain relief in patients
with chronic pain when using the Boston Scientic SCS Systems at subperception amplitude.
Of the 197 subjects that provided consent to participate in the study, 136 were randomized to either receive
subperception followed by supra-perception settings or vice versa for 90 days post-activation. The study
cohort was comprised of subjects who have been treated successfully with paresthesia-inducing stimulation
for at least six months.
Efcacy Outcomes
The study successfully met its primary effectiveness endpoint, demonstrating that the proportion of overall
pain responders at 90 days post-activation with subperception settings is non-inferior compared to supra-
perception settings at a statistically signicant level (p < 0.001). The study also successfully demonstrated
non-inferiority in the Per Protocol group indicating the robustness of the study.