Clinical Compendium BURST STIMULATION TECHNOLOGY A Novel Stimulation Mode for the Management of Chronic Intractable Pain

St. Jude Medical has the first and only CE-marked neurostimulation system that delivers both Burst and tonic spinal cord stimulation (SCS). 1 Burst stimulation technology has been shown to further reduce pain in tonic responders with a reduction in paresthesia and recapture pain relief in non-responders to traditional tonic stimulation. When used to manage chronic, intractable pain of the trunk and/or limbs, Burst stimulation is: ƒ Clinically proven – Significant pain reductions over tonic stimulation, 2-6 often with the reduction of paresthesia 2,3,5,7-8 as well as proven ability to recapture pain relief in patients who become unresponsive to tonic SCS 9-12 ƒ Preferred – Preferred over tonic stimulation by majority of patients 2,3,5-8 ƒ Safe and reliable – Approximately 90.0% of patients were free from device or system complications 2,3,6-8 Although it is an accepted standard of care for treatment of chronic pain, traditional tonic stimulation exhibits substantial heterogeneity in the level of pain relief 13 with up to 20 to 30% of patients classified as non-responders to the therapy. In addition, the paresthesia produced by tonic stimulation may introduce many challenges, including 1) inability to achieve adequate coverage in some areas such as the low back, 2) changes in intensity of paresthesia in response to changes in body position, 3) intolerance of the sensation by some patients, which can lead to a failed SCS trial and accommodation to the sensation such that it no longer provides adequate analgesic benefit. Burst stimulation, an alternative mode of stimulation where groups of pulses (rather than just a single pulse) are delivered to the spinal cord, 2,3 has recently been introduced and may address many of the issues associated with tonic SCS. This clinical compendium summarizes key studies demonstrating the safety and efficacy of Burst technology.