FDA approves St. Jude Medical’s BurstDR spinal cord stimulation for chronic pain

St. Jude Medical (NYSE:STJ) said today that the FDA granted pre-market approval for its BurstDR spinal cord stimulation technology, which is designed to mimic the body’s natural nerve-firing patterns to optimize SCS treatment for chronic pain.

The BurstDR technology is available with new implantations of St. Jude’s Proclaim Elite and Prodigy MRI SCS devices; it will also be available “soon” as a non-surgical upgrade to already-implanted Protégé and Proclaim SCS systems, Little Canada, Minn.-based St. Jude said.

The tech originated with research by Dr. Dirk De Ridder of Dunedin, New Zealand’s University of Otago, who filed the initial patents back in 2004, according to St. Jude. The FDA approval for the BurstDR therapy was based on data from the 100-patient Sunburst study, portions of which were presented late last year at the annual meeting of the North American Neuromodulation Society. An analysis of the 1st 85 patients to complete the 24-week protocol showed 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. More than 69% of patients preferred the Burst stimulation to traditional SCS, with 91% reporting decreased effects of paresthesia and 65% reporting no paresthesia.

“I am very excited that patients across the U.S. will now have access to BurstDR stimulation, which has enjoyed strong success across other global markets,” De Ridder said in prepared remarks. “When I developed BurstDR stimulation my goal was to introduce an entirely new therapy option, and 1 that was rooted in the natural way in which the human body responds to and combats the sensation of pain.”

“Chronic pain is 1 of the most costly epidemic diseases facing healthcare systems worldwide, and 1 of the most challenging for physicians to manage due to the complexity of the condition and the differences in each patient’s clinical case,” added St. Jude medical affairs VP Dr. Allen Burton. “With FDA approval of BurstDR stimulation, we are empowering physicians with a new therapy option in their fight against widespread chronic pain, and our goal is to continue to improve patient outcomes and get more patients the pain relief they deserve.”

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