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Wavewriter Alpha Spinal Cord Stimulation System Open Graph

Boston Scientific reports favorable data on spinal cord stimulation

Boston Scientific has unveiled positive outcomes after one year from a trial assessing its spinal cord stimulation (SCS) technology.

The SOLIS randomized control trial demonstrated enduring pain relief through the WaveWriter Alpha SCS system for the treatment of non-surgical back pain (NSBP). Boston Scientific disclosed the findings at the 2024 North American Neuromodulation Society (NANS) meeting held in Las Vegas.

Dr. James North presented the SOLIS findings, encompassing 128 randomized subjects. At the primary endpoint interval, 90% of patients treated with WaveWriter reported significant pain relief of 50% or more without an increase in opioid usage. In contrast, only 8% of patients treated solely with conventional medical management reported a similar level of relief.

After one year, 84% of patients treated with WaveWriter reported 50% or more pain relief and sustained enhancement in the ability to engage in daily activities. Boston Scientific noted a 25-point improvement in disability as measured by the Oswestry Disability Index (ODI).

Patients undergoing conventional medical management who later opted for SCS therapy experienced noteworthy improvements in pain and disability at the one-year mark. According to a press release, these outcomes remained comparable to subjects in the SCS arm, with 85% of crossover subjects reporting a 50% or greater reduction in pain and a mean 30-point improvement in ODI.

“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.”

The company also shared real-world results from 43 patients utilizing spinal cord stimulation (SCS) for painful diabetic peripheral neuropathy (DPN). The data indicated a substantial decrease in pain and noteworthy rates of patient improvement across all long-term assessments for SCS users.

In the two-year follow-up, 81% of patients reported experiencing a 50% or more reduction in pain. Over a period of up to three years, they consistently reported a high level of improvement and satisfaction with the treatment.

Boston Scientific additionally presented clinical outcomes involving fast-acting sub-perception-based therapy (FAST therapy). Various prospective and real-world studies demonstrated significant and enduring pain relief through the company’s exclusive FAST therapy.

FAST therapy was specifically designed to offer immediate, paresthesia-free relief from pain. At around the one-year follow-up mark, the studies observed consistent improvement. A minimum of 88% of SCS patients reported a 50% or more reduction in pain. The assessment of the 311 enrolled patients is still ongoing.

© Boston Scientific

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