FDA Approves New "Burst" Device for Spinal Cord Stimulation
The US Food and Drug Administration (FDA) has approved BurstDR device, a new form of spinal cord stimulation (SCS) with evidence of superior clinical benefits over traditional SCS therapy in the treatment of chronic pain.
BurstDR uses intermittent “burst” pulses to replicate the human body’s own natural nerve impulse patterns. The device is the first approved form of burst stimulation therapy studied in a large scale, multicenter randomized controlled clinical trial, according to researchers from St. Jude Medical, the company marketing the device.1
The device has been in development since 2004, when Dirk De Ridder, MD, PhD, from the University of Otago in Dunedin, New Zealand, filed the initial patents for a SCS device that could mirror the body’s own nerve impulses. Working in partnership with St. Jude Medical, the scientists were able to design a SCS therapy that may offer superior pain relief with higher patient satisfaction.
“I am very excited that patients across the United States will now have access to BurstDR stimulation, which has enjoyed strong success across other global markets,” said Professor De Ridder. “When I developed BurstDR stimulation, my goal was to introduce an entirely new therapy option, and one that was rooted in the natural way in which the human body responds to and combats the sensation of pain.”
The SUNBURST (Success Using Neuromodulation With BURST) trial, which is still ongoing, tested the BurstDR device against tonic SCS therapy using 100 patients, randomizing them to either receive Burst stimulation prior to tonic therapy or vice versa. At 24 weeks, preliminary analysis of the first 85 patients showed Burst stimulation achieved a statistically significant difference in improved pain relief and greater treatment success compared to tonic SCS.2
Most patients (91%) showed a decrease in paresthesia relative to tonic SCS therapy, and a majority of patients (65%) were completely paresthesia-free while using Burst stimulation. A strong majority of patients (69.4%) preferred the device. Results of the trial were presented back in December 2015 at the North American Neuromodulation Society Annual Meeting in Las Vegas, Nevada.
“Chronic pain is one of the most costly epidemic diseases facing health care systems worldwide, and one of the most challenging for physicians to manage due to the complexity of the condition and the differences in each patient’s clinical case,” said Allen W. Burton, M.D., medical director of neuromodulation and vice president of medical affairs at St. Jude Medical.
“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.”
According to the company, patients who are receiving new implants based off the St. Jude Medical Proclaim Elite and Prodigy MRI SCS systems will have access to the therapy immediately. BurstDR combined with the Proclaim Elite SCS System also will have a recharge-free option. As for patients previously implanted with Protégé and Proclaim SCS systems, they also will be able to upgrade their systems to incorporate BurstDR stimulation without any need for additional surgery.