FDA Approves St. Jude Medical BurstDR Neurostimulator For Chronic Back Pain

On October 4, 2016, St. Jude Medical, Inc., announced that the U.S. Food and Drug Administration (FDA) had approved its BurstDR™ implanted neurostimulation system for people with chronic back pain. BurstDR is a spinal cord stimulator (SCS). Rather than providing constant stimulation to control pain, the BurstDR system uses intermittent pulses designed to mimic the body’s natural nerve impulse patterns.

The BurstDR system was evaluated in a large scale, multicenter randomized controlled clinical trial called the SUNBURST Study. The system generated superior pain relief over traditional spinal cord stimulation. The FDA approval of BurstDR stimulation will allow people . . .