FDA APPROVES BOSTON SCIENTIFIC SCS SYSTEMS FOR TREATMENT OF NON-SURGICAL BACK PAIN

Boston Scientific announced that the U.S. Food and Drug Administration (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).

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 life and reduced opioid use.

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.