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Clinical Summary for BurstDR™ Stimulation
Abbott Medical performed a clinical study to establish reasonable assurance of safety and
effectiveness of BurstDR™ stimulation for the treatment of chronic, intractable pain of the trunk
and/or limbs. The following sections present information and results for the SUNBURST™ study.
SUNBURST™ Study Design
Subjects began to enroll in the study in January 2014, and treatment has continued through the
time of this report. This report includes the data collected through February 2016, accounting for
173 subjects at a total of 20 investigational sites.
The study was a prospective, multicenter, randomized, open-label, crossover study that compared
two different stimulation modes:
Arm 1: tonic-then-burst stimulation (tonic/burst)
Arm 2: burst-then-tonic stimulation (burst/tonic)
Subjects with chronic intractable pain of the trunk and/or limbs were informed about the study to
determine if they were interested in participating. After subjects signed an informed consent
agreement, they were screened according to the inclusion and exclusion criteria and underwent a
baseline evaluation. Those subjects who met the criteria to participate were scheduled to receive a
commercially available Abbott Medical trial neurostimulation system for spinal cord stimulation
(SCS). Subjects underwent a trial period using tonic stimulation, and those subjects who
completed the trial successfully were scheduled to receive a Prodigy™ neurostimulation system,
which is capable of delivering both stimulation modes.