FDA expands indication for spinal cord stimulation system to cover nonsurgical back pain
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Key takeaways:
- The WaveWriter is approved to treat low back and leg pain in patients without prior back surgery.
- The system provided “significant and sustained pain relief” to patients in a randomized controlled trial.
The FDA has expanded approval for Boston Scientific’s WaveWriter spinal cord stimulation system to include treatment of chronic low back and leg pain in patients who have not had previous back surgery.
The expanded indication for nonsurgical back pain extends use of the WaveWriter system to “patients who have had limited options for treating their lower back pain,” James North, MD, of the Carolinas Pain Institute, said in a press release from Boston Scientific.
![A quote from Jim Cassidy saying, "Early and effective intervention with [spinal cord stimulation] therapy is associated with long-term success and improved outcomes for people living with chronic back pain."](/~/media/slack-news/rheumatology/misc/infographics/2024/rh0224north_graphic_01.jpg?w=800)
The FDA’s approval was based on positive 1-year data from a randomized controlled trial –SOLIS or “SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery” – which achieved its primary endpoint of more than 50% pain reduction after 3 months.
The WaveWriter system provided “significant and sustained pain relief,” with 84% of patients reporting improved ability to participate in daily activities a year after treatment, according to the release.
“Early and effective intervention with [spinal cord stimulation] therapy is associated with long-term success and improved outcomes for people living with chronic back pain,” Jim Cassidy, president of neuromodulation at Boston Scientific, said in the release. “Today’s approval, combined with the recent indication for diabetic peripheral neuropathy, extends the reach of our robust portfolio to help physicians deliver individualized care across a wide spectrum of lower back pain issues.”
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