ON average, people who received SCS therapy experienced a 69.7% reduction in pain. In the study, 91.4% of people who received SCS therapy obtained significant pain relief or significantly improved function. 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.Īll of Abbott’s SCS therapies in the US feature the company’s proprietary, low-energy BurstDR waveform, which had efficacy further supported by DISTINCT. 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. The new indication spans across the entire SCS program, which includes the recharge-free Proclaim SCS family and the rechargeable Eterna SCS platform. 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.
