St. Jude Touts Positive Data From BURST Neurostimulation Trial
By Jof Enriquez,
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St. Jude Medical presented during the 19th Annual Meeting of the North American Neuromodulation Society (NANS) in Las Vegas, Nevada, positive results from a clinical trial of its Burst stimulation technology over traditional spinal cord stimulation (SCS) in reducing chronic pain and paresthesia — a tingling, or "pins and needles" sensation associated with traditional neurostimulators.
The SUNBURST (Success Using Neuromodulation With BURST) Study is a prospective, randomized study of 100 patients from 20 centers across the United States who received either tonic stimulation prior to Burst stimulation, or Burst stimulation prior to tonic stimulation. After six months, results showed that majority of patients who received Burst therapy reported superior pain relief compared to traditional tonic SCS, according to a press release. Data showed that 69.4 percent of participants preferred Burst stimulation over tonic SCS in reducing pain. Further, 91 percent of patients reported a decrease in paresthesia during treatment, while 65 percent said they did not experience paresthesia while receiving Burst stimulation.
“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,” said Timothy R. Deer, M.D., president and CEO of The Center for Pain Relief in Charleston, W.V., and chairman of the SUNBURST study, in the release. “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.”
According to National Institutes of Health (NIH) figures, chronic pain affects approximately 1.5 billion people worldwide, including 100 million in the U.S. Although traditional SCS systems have proven effective in reducing chronic pain, some 20 to 30 percent of patients do not respond well to traditional SCS therapy, while some may experience diminished benefits from SCS over time.
Recent device development in neurostimulation is geared not only toward pain relief, but also the reduction of paresthesia. St. Jude's approach is to mimic the body's natural nerve physiology by firing intermittent "burst" pulses to respond to pain signals while minimizing paresthesia. The company introduced to the market its Burst stimulation in 2014 with the launch of the original Prodigy chronic pain system. St. Jude will be using the findings from the SUNBURST trial to support FDA approval for the latest in the Prodigy rechargeable series, as well as for the Protégé rechargeable and the Proclaim non-rechargeable SCS devices.
Presently, St. Jude has the exclusive right to market Burst stimulation outside the U.S. domestic market, according to Yahoo Finance. The company also recently announced the European launch of the Proclaim Elite upgradeable and non-rechargeable SCS system approved to deliver burst stimulation. St. Jude also received in August the CE Mark for Prodigy as the only MR-conditional rechargeable SCS system.