FDA approves spinal cord stimulation system for chronic, nonsurgical back pain
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Abbott has announced the FDA expanded the indication of its BurstDR spinal cord stimulation devices for treating chronic back pain in those who have not had or are ineligible for back surgery.
The approval was based on results from the DISTINCT study, which showed that patients with chronic back pain who were treated with the BurstDR spinal cord stimulation (SCS) technology reported improvements in pain levels, ability to perform daily activities and emotional well-being, according to an Abbott press release.
Abbott has announced the FDA expanded the indication of its BurstDR spinal cord stimulation devices for treating chronic back pain in those who have not had or are ineligible for back surgery.
In August 2022, the FDA granted premarket approval for Abbott’s Proclaim Plus SCS system featuring FlexBurst360 therapy, the next generation of Abbott’s BurstDR stimulation technology, for chronic pain across up to six areas of the body.
“This FDA expanded indication approval for our SCS devices is a significant step forward in Abbott’s goal to provide treatment access to those who suffer daily with chronic back pain but are not eligible for corrective surgery,” Pedro Malha, Abbott’s vice president of neuromodulation, said in the release.
BurstDR uses pulses of mild electrical energy without paresthesia to change pain signals as they travel from the spinal cord to the brain, the company explained in the release. This technology has been shown to improve ability to perform daily activities and reduce emotional suffering associated with chronic pain.
“To date, we have struggled with how to treat people who weren’t considered a good surgical candidate because we didn’t have clear, data-driven treatment options for nonsurgical back pain,” Timothy Deer, MD, FIPP, DABPM, president and CEO of the Spine and Nerve Centers of the Virginias in Charleston, West Virginia, said in the release. “This new indication for Abbott’s SCS devices, together with BurstDR stimulation, allows physicians the ability to identify and treat a new group of people, providing them with relief from chronic back pain.”
The company said this new indication will apply to its entire U.S. portfolio of SCS technology, which includes the Proclaim SCS family and the Eterna SCS platform.