Abbott has announced that the US Food and Drug Administration (FDA) has approved its 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—known as non-surgical back pain. This labeling expansion was supported by results from the DISTINCT study, which demonstrated that the company’s proprietary BurstDR SCS technology improved pain levels, ability to perform daily activities and emotional wellbeing in people with chronic back pain, a press release notes.
“To date, we have struggled with how to treat people who were not considered a good surgical candidate because we did not have clear, data-driven treatment options for non-surgical back pain,” said Timothy Deer (Spine and Nerve Centers of the Virginias, Charleston, USA). “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.”
Abbott’s DISTINCT study, which enrolled 270 participants who suffered for an average of 12.8 years with pain, is the largest randomised controlled trial for SCS in people with chronic back pain when surgery is not an option, the release further claims. Results at six months for the first 200 patients demonstrated clear clinical evidence supporting BurstDR stimulation therapy as an effective treatment for chronic back pain and were sustained at the 12-month follow-up.
Additional key findings from the DISTINCT study included:
- Some 72.6% of people in the SCS study arm and 85.2% of those implanted achieved significant back pain reduction compared to only 7.1% in the conservative medical management arm
- Some 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
This new indication will span across the entirety of Abbott’s SCS portfolio in the USA, which includes the recharge-free Proclaim SCS family and the rechargeable Eterna SCS platform. According to the company, all of Abbott’s SCS therapies in the USA feature the company’s proprietary, low-energy BurstDR waveform.
“This FDA [Food and Drug Administration] 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,” said Pedro Malha, vice president, neuromodulation, Abbott.