St. Jude Medical, Inc., a global medical device company, has announced the SUNBURST study has demonstrated that Burst stimulation from St. Jude Medical is superior to traditional tonic spinal cord stimulation (SCS) in relieving chronic pain. The SUNBURST study also found patients preferred Burst stimulation to traditional SCS and that a vast majority of patients experienced a reduction in paresthesia (a tingling sensation common during traditional SCS), or were paresthesia free when receiving Burst stimulation. The results of the SUNBURST study, a prospective, randomized multicenter study designed to support U.S. approval of St. Jude Medical's Burst stimulation, were presented today during a plenary session at the 19th annual meeting of the North American Neuromodulation Society (NANS) in Las Vegas, Nevada.
"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 chief executive officer of The Center for Pain Relief in Charleston, West Virginia, and Chairman of the SUNBURST study. "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."
The SUNBURST study was designed to assess the effects of Burst stimulation from St. Jude Medical, and enrolled 100 patients from 20 centers across the United States randomized to either receive tonic stimulation prior to Burst stimulation, or to receive Burst stimulation prior to tonic stimulation. After six months, an analysis of the first 85 patients to complete their 24 week visit showed Burst stimulation delivered:
- Superior pain relief: The study met its primary endpoint of non-inferiority and achieved statistical significance for its pre-specified secondary endpoint of superiority demonstrating patients receiving St. Jude Medical's Burst stimulation achieved superior pain relief and greater treatment success when compared to patients receiving traditional SCS.
- Patient preference: A statistically significant majority of patients (69.4 percent) in the SUNBURST study preferred Burst stimulation to tonic SCS for the treatment of chronic pain.
- Reduced paresthesia: The vast majority (91 percent) of patients reported a decrease in paresthesia during treatment with Burst stimulation relative to tonic SCS. In addition, 65 percent of SUNBURST patients were paresthesia free while using Burst stimulation from St. Jude Medical.
"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," said Allen Burton, M.D., medical director of neuromodulation and vice president of medical affairs at St. Jude Medical. "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."
According to the National Institutes of Health (NIH), chronic pain is typically defined as pain lasting longer than 12 weeks. The condition, which affects approximately 1.5 billion people worldwide, can take a physical and emotional toll on patients, many of whom try many different types of treatment options on their path to finding pain relief. Traditional tonic SCS has been proven to offer meaningful chronic pain relief for many patients, but between 20 to 30 percent of patients do not respond to tonic SCS therapy while some patients may see a reduced benefit from the therapy over time.
The proprietary Burst stimulation developed by St. Jude Medical works differently from other stimulation designs, utilizing intermittent "burst" pulses designed to mimic the body's natural nerve firing patterns and provide a more physiologic therapy method for chronic pain conditions. St. Jude Medical is the only company approved to offer patients outside the United States Burst stimulation, which was introduced after a nearly a decade of research and study in collaboration with Dirk De Ridder, M.D., Ph.D., who filed the therapy's initial patents in 2004. The results of the SUNBURST study are being used to support St. Jude Medical's application for FDA approval of Burst therapy feature in the Prodigy and Protégé rechargeable SCS devices, as well the Proclaim non-rechargeable system.