St. Jude touts Burst SCS study

St. Jude Medical (NYSE:STJ) today released data from the Sunburst study examining its Burst spinal cord stimulation neuromodulation therapy, touting its chronic-pain relieving ability compared to traditional tonic spinal cord stimulation.

The results were presented at the North American Neuromodulation Society’s annual meeting in Las Vegas this weekend, the company said.

St. Jude said the results of the 100-patient, 20 center U.S. Sunburst trial will be used to support the FDA approval of the Burst therapy feature in its Prodigy and Protege rechargeable SCS devices and Proclaim non-rechargeable systems.

“We are excited to report the positive results of the Sunburst study, which shows Burst stimulation can provide patients additional options to effectively manage their chronic pain. Many U.S. pain physicians and their patients have long been hopeful for new options to treat chronic pain, and now the Sunburst trial has clinically demonstrated that Burst stimulation is a meaningful therapy to support improved management of chronic pain while reducing, and in the majority of patients eliminating, paresthesia,” study chair Dr. Timothy Deer of Charleston, W.V.’s Center for Pain Relief said in a press release.

An analysis of the 1st 85 patients to complete the 24-week visit indicated that the study met its primary endpoint of non-inferiority and “achieved statistical significance” in its secondary endpoint demonstrating superior pain relief and greater treatment success compared to traditional SCS.

The study reported 69.4% of patients preferred the Burst stimulation to traditional SCS, and 91% reported decreased effects of paresthesia while 65% reported no paresthesia.

“St. Jude Medical is committed to developing solutions that can reduce the effect of complex epidemic diseases while improving patient care, and providing new treatment options for patients suffering from chronic pain is central to that goal. The results of the Sunburst study have provided strong confirmation that our Burst stimulation therapy yields direct benefits for patients while offering superior pain relief and improved quality of life,” medical affairs veep Dr. Allen Burton said in prepared remarks.

St. Jude’s Burst stimulation is designed to mimic the body’s natural nerve firing patterns to “provide a more physiologic therapy method for chronic pain conditions,” the company said.

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