Abbott’s SCS Systems OK’ed for Back Pain Patients with Limited Surgical Options

Abbott Labs has earned U.S. Food and Drug Administration (FDA) approval for its spinal cord stimulation (SCS) devices to treat chronic back pain in patients who haven’t had, or aren’t eligible to receive, back surgery—this is known as non-surgical back pain.
 
The label expansion was supported by results from the DISTINCT study, which showed Abbott’s BurstDR SCS technology improved pain level, ability to perform daily activities, and emotional well-being in chronic back pain patients.
 
The new indication spans the whole of Abbott’s SCS portfolio in the U.S. This includes the Proclaim SCS family and rechargeable Eterna SCS platform—Eterna was granted FDA approval for use during MRI scans last week. All of Abbott’s U.S. SCS therapies feature the company’s low-energy BurstDR waveform.
 
BurstDR stimulation therapy uses pulses (or bursts) of mild electrical energy without the sensation of paresthesia to change pain signals as they travel from the spinal cord to the brain.
 
“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 CEO of the Spine and Nerve Centers of the Virginias, told the press. “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 DISTINCT study examined 270 participants who suffered for an average 12.8 years with pain. According to Abbott, it’s the largest randomized controlled trial for SCS in chronic back pain patients when surgery isn’t an option. Results at six months for the first 200 patients showed “clear clinical evidence” supporting BurstDR stimulation therapy as effective for chronic back pain, and were sustained at 12-month follow-up.
 
72% of patients in the SCS study arm and 85.2% of those implanted achieved “significant” back pain reduction, compared to 7.1% in the conservative management arm. 91.4% of SCS therapy subjects obtained significant pain relief or significantly improved function. And on average, those who underwent SCS therapy experienced 69.7% reduction in pain.