St. Jude Medical has received approval from the US Food and Drug Administration (FDA) for its BurstDR stimulation to treat patients suffering chronic pain.
BurstDR is a physician-designed form of spinal cord stimulation (SCS), which is exclusive to
The new SCS option uses intermittent burst pulses designed to mimic the body’s natural nerve impulse patterns.
St. Jude Medical’s BurstDR stimulation is claimed to be the only approved form of burst stimulation that has been assessed in a large scale, multicenter randomized controlled clinical trial.
According to the company, the SUNBURST randomized multicenter study confirmed BurstDR stimulation provided better pain relief over traditional SCS.
BurstDR stimulation was developed in collaboration with professor Dirk De Ridder, who filed the therapy’s initial patents in 2004.
Pateints already receiving the firm’s Proclaim Elite and Prodigy MRI spinal cord stimulation systems can access the new therapy.
Additionally, patients previously implanted with upgradeable Protégé and
St. Jude Medical medical affairs vice president and neuromodulation medical director Dr Allen Burton said: “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.
“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.”