Boston Scientific today announced that the FDA has approved an expanded indication of the WaveWriter SCS Systems for the treatment of chronic low back and leg pain in people without prior back surgery, commonly referred to as non-surgical back pain (NSBP).
″Diagnosing and treating chronic low back pain can be challenging,″ said James North, M.D. Carolinas Pain Institute and principal investigator of the SOLIS trial. ″The new indication for NSBP expands the use of the WaveWriter SCS Systems to patients who have had limited options for treating their lower back pain.″
First-line treatment for people with chronic back pain is usually limited to conventional medical management such as physical therapy and medication, which are not effective for many people. Effective chronic pain management may lead to improved quality of lifei and reduced opioid use.
″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.″
The expanded indication is backed by positive one-year data from the SOLIS (SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery) randomized control trial, which met its primary endpoint (≥50% reduction in pain) at three-month interval and demonstrates that the WaveWriter SCS Systems provide significant and sustained pain relief. Followed out to one year, 84% of patients treated with the WaveWriter Systems reported significant pain relief of ≥50% and sustained improvement in their ability to participate in activities of daily living, with a mean 25-point improvement in disability as measured by the Oswestry Disability Index.