Sam Brusco, Associate Editor02.06.24
Boston Scientific has gained expanded indication from the U.S. Food and Drug Administration for its WaveWriter spinal cord stimulation (SCS) systems, in order to treat chronic low back leg pain in patients without previous back surgery. This is also known as non-surgical back pain (NSBP).
The expansion is supported by positive one-year data from the SOLIS (SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery) RCT, which met its primary endpoint (≥50% reduction in pain) at three-month interval and showed the WaveWriter SCS provide significant and sustained pain relief.
Followed to one year, 84% of patients treated with the WaveWriter systems reported pain relief of ≥50% and sustained improvement in the ability to participate in activities of daily living, with a mean 25-point improvement in disability, as measured by the Oswestry Disability Index.
First-line treatment for chronic back pain is typically physical therapy and medication, which aren’t effective for many patients.
″Early and effective intervention with SCS therapy is associated with long-term success and improved outcomes for people living with chronic back pain,″ said Jim Cassidy, president, Neuromodulation, Boston Scientific. ″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.″
Learn more about spinal cord stimulation and other tech to treat chronic pain here!
The expansion is supported by positive one-year data from the SOLIS (SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery) RCT, which met its primary endpoint (≥50% reduction in pain) at three-month interval and showed the WaveWriter SCS provide significant and sustained pain relief.
Followed to one year, 84% of patients treated with the WaveWriter systems reported pain relief of ≥50% and sustained improvement in the ability to participate in activities of daily living, with a mean 25-point improvement in disability, as measured by the Oswestry Disability Index.
First-line treatment for chronic back pain is typically physical therapy and medication, which aren’t effective for many patients.
″Early and effective intervention with SCS therapy is associated with long-term success and improved outcomes for people living with chronic back pain,″ said Jim Cassidy, president, Neuromodulation, Boston Scientific. ″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.″
Learn more about spinal cord stimulation and other tech to treat chronic pain here!