The FDA approved St. Jude Medical’s physician-designed spinal cord stimulation system for the treatment of chronic pain. Treatment with the BurstDR system differs from traditional SCS therapy in that it delivers “burst” pulses of stimulation that mirror the body’s natural nerve impulses.
In SCS, an implant is placed beneath the skin to deliver neurostimulation to a patient’s spinal cord. A number of players, such as Medtronic and Nevro, are studying neurostimulation for various indications, including movement and psychological disorders and overactive bladder in addition to chronic pain management.
“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 Dr. Allen Burton, medical director of neuromodulation and vice president of medical affairs at St. Jude Medical, in a statement. Many patients seeking treatment for chronic pain find only partial relief. By echoing the body’s natural pain response patterns, St. Jude’s BurstDR offers a “more complete” pain management option, the company said.
The approval of St. Jude’s BurstDR system comes after a decade of work, the company said in the statement. It was found in a prospective, randomized, multicenter study to provide “superior pain relief” over traditional spinal cord stimulation, according to the statement. Most of the trial participants preferred BurstDR over traditional therapy.
Other companies are working on stimulation that mimics patients’ natural nerve impulse patterns, but BurstDR is the first FDA-approved form of burst stimulation that has been assessed in a large-scale trial, according to the company. The treatment will be available immediately to patients getting new implants of the Proclaim Elite and Prodigy MRI spinal cord stimulation systems. Patients who have already received the upgradeable Protég and Proclaim systems will soon be able to upgrade their systems and receive BurstDR therapy, St. Jude said in the statement.