The Food and Drug Administration (FDA) has expanded the approval of Abbott’s spinal cord stimulation (SCS) devices for the treatment of chronic back pain in people who have not had or are not eligible to receive back surgery.
The new indication applies to Abbott’s Proclaim™ SCS products and the Eterna SCS platform. These devices use proprietary BurstDR stimulation technology to deliver pulses of mild electrical energy to alter pain signals traveling from the spinal cord to the brain.
The expanded approval was supported by data from the DISTINCT study (ClinicalTrials.gov Identifier: NCT04479787), which evaluated the efficacy of the BurstDR SCS therapy in adults with chronic back pain (average of 12.8 years of pain) who had not had or were ineligible for surgery. Compared with conventional medical management (eg, physical therapy, medications, injections, acupuncture, massage therapy), patients who received SCS therapy achieved significant back pain reduction at 6 months that was sustained at the 12-month follow-up.
Abbott’s SCS systems are also indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome or diabetic peripheral neuropathy of the lower extremities.
This article originally appeared on MPR
Abbott receives FDA approval for its spinal cord stimulation systems to treat chronic back pain in people who have limited surgical options. News release. Abbott. Accessed May 16, 2023. https://www.prnewswire.com/news-releases/abbott-receives-fda-approval-for-its-spinal-cord-stimulation-systems-to-treat-chronic-back-pain-in-people-who-have-limited-surgical-options-301825846.html.