Boston Scientific Corporation announced today that the US Food and Drug Administration (FDA) has approved an expanded indication of the company’s WaveWriter spinal cord stimulation (SCS) systems for the treatment of chronic low back and leg pain in people with non-surgical back pain (NSBP).
″Diagnosing and treating chronic low back pain can be challenging,” said James North (Carolinas Pain Institute, Winston-Salem, USA), 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.”
Firstline treatment for people with chronic back pain is usually limited to conventional medical management strategies, such as physical therapy and medication, which are not effective for many people, according to Boston Scientific. A recent press release from the company also states that effective chronic pain management may lead to improved quality of life 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 individualised care across a wide spectrum of lower back pain issues.”
Boston Scientific claims that this expanded indication is backed by positive one-year data from the SOLIS randomised controlled trial, which North delivered via a late-breaking presentation at last month’s North American Neuromodulation Society (NANS) annual meeting (18–21 January, Las Vegas, USA).
SOLIS met its primary endpoint (≥50% reduction in pain) at a three-month interval, and thus demonstrated that WaveWriter SCS systems provide “significant and sustained pain relief”, as per Boston Scientific’s recent release. Followed out to one year, 84% of patients treated with WaveWriter systems reported significant pain relief of ≥50% and sustained improvements in their ability to participate in activities of daily living, with a mean 25-point improvement in disability on the Oswestry disability index (ODI).
