The SOLIS randomized control trial demonstrated sustained pain relief with the WaveWriter Alpha SCS system for treating non-surgical back pain (NSBP). Boston Scientific presented data at the 2024 North American Neuromodulation Society (NANS) meeting in Las Vegas.
Dr. James North presented findings from SOLIS, which evaluated 128 randomized subjects. At the primary endpoint interval, 90% of patients treated with WaveWriter 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 and 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).
Conventional medical management patients who subsequently chose SCS therapy achieved significant improvements in pain and disability at one year. According to a news release, they remained consistent with subjects in the SCS arm. Boston Scientific said 85% of crossover subjects reported a 50% or greater reduction in pain with a mean 30-point ODI improvement.
“Continued positive results from the SOLIS study illustrate the need for early and effective pain treatment when just the standard of care is not enough,” said Jim Cassidy, president, Neuromodulation, Boston Scientific. “Backed by consistently strong clinical evidence, our transformative pain management solutions help individualize care and improve the quality of life for the many people living with chronic pain today.”
More SCS data from Boston Scientific
The company also reported real-world outcomes from 43 patients using SCS for painful diabetic peripheral neuropathy (DPN). Data showed a profound reduction in pain and high rates of patient improvement across all long-term points for SCS users.
At the two-year follow-up, 81% of patients reported a 50% or greater reduction in pain. Up to three years, they reported a high level of improvement and treatment satisfaction as well.
Boston Scientific also reported clinical outcomes using fast-acting sub-perception-based therapy (FAST therapy). Multiple prospective and real-world studies showed significant and sustained pain relief using the proprietary FAST therapy.
The company designed FAST therapy to provide immediate, paresthesia-free pain relief. At approximately one year follow-up, the studies saw consistent improvement. At least 88% of SCS patients reported 50% or greater pain relief. The evaluation of 311 enrolled patients remains ongoing.
