The Abbott Park, Ill.-based company released an additional sub-study analysis from the Sunburst trial, which reported that the benefits from standardizing BurstDR stimulation could improve clinical outcomes and show symptom improvement for chronic pain patients.
Analysis of the Sunburst study and the programming optimization sub-study was presented at the 2017 North American Neuromodulation Society’s annual meeting.
“Results from the full data cohort of the Sunburst study provide important confirmation of the clinical value of BurstDR stimulation in the treatment of chronic pain, a condition for which new therapeutic options have been urgently needed for some time. BurstDR stimulation is a highly effective new tool in the management of chronic pain while reducing and even eliminating paresthesia in many patients. Importantly, since the launch of the therapy in the U.S. we have seen positive clinical outcomes nationwide that have reinforced and even built on the results of the Sunburst study,” Dr. Konstantin Slavin of the University of Illinois College of Medicine at Chicago said in a prepared statement.
Data from an intent-to-treat analysis of the Sunburst study indicated that the BurstDR stimulation met both non-inferiority and superiority endpoints compared to traditional tonic SCS.
Additional data indicated that 89% of patients treated with BurstDR reported less paresthesia compared to tonic SCS, with more than 61% of patients experiencing no paresthesia at all. Overall, more than 70% of patients said they preferred BurstDR therapy.
In the programming optimization sub-study, 59% of patients achieved approximately 60% reduction on the pain intensity measurement Visual Analog Scale. Data also indicated that 91% of the sub-study patients experienced no paresthesia with BurstDR therapy.
“The clinical experience with BurstDR stimulation in Europe made it clear that we could further improve patient outcomes with the therapy by optimizing programming to generate strong pain relief while reducing or eliminating paresthesia. This sub-study shows that we can continue to maximize patient benefits with BurstDR stimulation and build upon the superior pain relief delivered by the therapy over traditional tonic spinal cord stimulation therapy,” Abbott neuromod medical director Dr. Allen Burton said in a press release.
The BurstDR tech, which is designed to improve spinal cord stimulation effectiveness for chronic pain patients, originated with research by Dr. Dirk De Ridder of Dunedin, New Zealand’s University of Otago, who filed the initial patents back in 2004. The technology uses intermittent “burst” pulses which attempt to mimic the body’s natural nerve impulse patterns.
In October, St. Jude said that the FDA granted pre-market approval for its BurstDR spinal cord stimulation technology.
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