The indication covers chronic low back and leg pain in people without prior back surgery — called non-surgical back pain (NSBP).
Boston Scientific says first-line treatment for people with chronic back pain tends to have limitations. Conventional medical management like physical therapy and medication tend to prove less effective for many people. Effective chronic pain management may lead to improved quality of life and reduced opioid use.
In a news release, Dr. James North of the Carolinas Pain Institute said this expanded indication helps people with limited treatment options. North also served as the principal investigator for the SOLIS trial of the technology for treating NSBP.
Boston Scientific presented positive data from the SOLIS trial last month, which supported the expanded FDA indication.
At the primary endpoint interval, 90% of WaveWriter patients reported significant pain relief of 50% or greater without an increase in opioids. Just 8% of patients treated with conventional medical management alone reported the same level of relief.
At one year, 84% of patients treated with WaveWriter reported 50% or greater pain relief. They also demonstrated sustained improvement in the ability to participate in activities of daily living. Boston Scientific reports a 25-point improvement in disability measured by the Oswestry Disability Index (ODI).
″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.″
