Comprised of the recharge-free Proclaim SCS family and the rechargeable Eterna SCS platform, the approval for Abbott’s spinal cord stimulation system was backed by the large-scale, DISTINCT study.
According to an announcement, the FDA has approved Abbott’s spinal cord stimulation (SCS) devices for the treatment of chronic back pain in individuals who have not or are not eligible to receive back surgery. The new indication spans across the entire SCS program, which includes the recharge-free Proclaim SCS family and the rechargeable Eterna SCS platform.
The approval was based on the DISTINCT study (NCT0447987), the largest randomized controlled trial for SCS in people with chronic back pain for which surgery is not an option. Comprised of 270 individuals who suffered an average of 12.8 years with pain, 72.6% of those in the SCS study arm and 85.2% of those implanted achieved significant back pain reduction compared with only 7.1% of individuals in the conventional medical management (CMM) arm.
All of Abbott’s SCS therapies in the US feature the company’s proprietary, low-energy BurstDR waveform, which had efficacy further supported by DISTINCT. In the study, 91.4% of people who received SCS therapy obtained significant pain relief or significantly improved function. ON average, people who received SCS therapy experienced a 69.7% reduction in 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 non-surgical back pain,” Timothy Deer, MD, FIPP, DABPM, president and chief executive officer, Spine and Nerve Centers of the Virginias, Charleston, West Virginia, said in a statement.1 "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."
Additional findings from DISTINCT were presented at the 37th Annual Meeting of the North American Spine Society in 2022, further supporting the efficacy of the SCS systems. After the 6-month trial period, 87% of patients reported at least 50% pain relief and NRS scores for low back pain decreased from 7.7 to 2.5. Following the trial, 125 percutaneous and 50 paddle leads were implanted, most (96%) of which were between T7 and T9. Those on SCS continued to report superior meaningful reductions in pain intensity and low back pain-related disability compared with CMM. Pain-related emotional distress was also improved in the SCS treatment arm in relation to CMM.
"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, vice president, Neuromodulation, Abbott, said in a statement.