The FDA approval was supported by Abbott's DISTINCT study, which showed that BurstDR SCS technology improved pain levels, ability to perform daily activities and emotional well-being in people with chronic back pain
Abbott’s SCS systems can now treat chronic back pain. (Credit: CHUTTERSNAP on Unsplash)
Abbott has received the US Food and Drug Administration (FDA) approval for its spinal cord stimulation (SCS) devices to treat chronic back pain in people who are not eligible for surgery.
The new indication is applicable across the company’s entire portfolio of SCS systems in the US, including the recharge-free Proclaim SCS and the rechargeable Eterna SCS platform.
All the above devices feature BurstDR, a form of stimulation therapy that uses pulses, or bursts, of mild electrical energy to change pain signals as they travel from the spinal cord to the brain.
According to previous studies, BurstDR therapy is more comfortable and preferred to traditional tingling tonic stimulation by 70.8% of people with chronic pain.
Spine and Nerve Centres of the Virginias president and chief executive officer Timothy Deer said: “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.
“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.”
The expanded FDA approval is supported by results from the DISTINCT study, which evaluated BurstDR SCS technology compared to conventional medical management (CMM).
DISTINCT, the largest randomised controlled trial (RCT) for SCS, has enrolled 270 participants who suffered for an average of 12.8 years with pain.
In the study, treatment using BurstDR SCS technology improved pain levels, ability to perform daily activities and emotional well-being in people with chronic back pain.
In total, 72.6% of participants in the SCS study arm experienced a significant reduction in back pain compared to only 7.1% in the conservative medical management arm.
In addition, 91.4% of people who received SCS therapy experienced significant pain relief, and an average of 69.7% of people who received SCS therapy experienced pain reduction.
Abbott neuromodulation vice president Pedro Malha said: “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.”