The US Food and Drug Administration (FDA) has expanded the indication for Abbott Laboratories' spinal cord stimulation (SCS) devices to include treatment of chronic back pain in patients who have not had, or are not eligible for, back surgery, the company has announced.
The new indication spans all of Abbott's SCS devices in the US, which include the recharge-free Proclaim SCS family and the rechargeable Eterna SCS platform.
The devices feature the company's proprietary, low-energy BurstDR stimulation waveform, a form of stimulation therapy that uses bursts of mild electrical energy without causing an abnormal tingling sensation to help disrupt pain signals before they can reach the brain, the company explains.
The expanded indication was supported by results from the DISTINCT study, which enrolled 270 adults suffering from severe, disabling chronic back pain for an average of more than 12 years and who were not eligible for surgery.
The study showed that significantly more patients who were treated with SCS achieved significant improvements in back pain, function, quality of life, and psychological status than peers treated with conservative medical management.
"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 non-surgical back pain," Timothy Deer, MD, president and CEO of the Spine and Nerve Centers of the Virginias in Charleston, West Virginia, said in a news 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," Deer adds.
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Cite this: FDA OKs Spinal Cord Stimulation Devices for Chronic Back Pain - Medscape - May 16, 2023.