The US Food and Drug Administration has expanded the indication of Abbott Laboratories’ Spinal Cord Stimulation (SCS) devices, including treatment of chronic backache in patients who are not eligible or have not undergone back surgery.
The new indication covers all Abbott SCS devices sold in the US. This includes the rechargeable Eterna SCS and the Proclaim SCS platforms.
The devices use the company’s proprietary low-energy BurstDR waveform. This is a form stimulation therapy that uses mild electrical energy bursts without causing an abnormal sensation to disrupt pain signals before the brain can reach them, the company explains.
The DISTINCT study results, which enrolled 270 adult patients with severe, disabling, chronic back pain, who had been suffering for more than 12 years on average, and were not eligible for surgical intervention, supported the expanded indication.
The study found that SCS significantly improved back pain, function and quality of life in patients compared to those treated with conventional medical management.
“To date, we’ve struggled to treat people who aren’t considered good surgical candidates because we didn’t know how to treat them. We didn’t have clear and data-driven options for nonsurgical back pain,” Timothy Deer MD, president and chief executive officer of the Spine and Nerve Centers of the Virginias, in Charleston, West Virginia said in a press release.
Deer continues, “This new indication of Abbott’s SCS device, combined with BurstDR, allows physicians to identify a new group, and provide them with relief from back pain.”
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