MARLBOROUGH, Mass. and LAS VEGAS, Jan. 20, 2024 – Boston Scientific Corporation (NYSE: BSX) today announced positive one-year results from the SOLIS randomized control trial, demonstrating sustained pain relief using the WaveWriter Alpha™ Spinal Cord Stimulation (SCS) Systems for the treatment of non-surgical back pain (NSBP). All data were presented at the 2024 North American Neuromodulation Society (NANS) meeting held in Las Vegas, Nevada.

"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.”

SOLIS randomized control study with WaveWriter and WaveWriter Alpha SCS Systems

Outcomes from the SOLIS study, which had met its primary endpoint, were highlighted in a late-breaking data presentation by James North, M.D. Key findings from the study (n = 128 randomized subjects):

• At the primary endpoint interval, 90% of patients treated with the WaveWriter Systems reported significant pain relief of 50% or greater without an increase in opioids, compared with 8% of patients treated with conventional medical management (CMM) alone (p < 0.0001).
• At one year, 84% of patients treated with the WaveWriter Systems reported significant pain relief of 50% or greater 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 (ODI).
• CMM patients who subsequently chose to receive SCS therapy achieved significant improvement in pain and disability at one year interval, consistent with subjects in the SCS arm; 85% of crossover subjects reported a 50% or greater reduction in pain with a mean 30-point improvement in disability as measured by ODI.

Global, multicenter study of prospectively-enrolled patients utilizing SCS for Painful-Diabetic Peripheral Neuropathy (DPN)

Real-world outcomes from the study (n=43) demonstrated a profound reduction in pain and high rates of patient improvement across all long-term time points using SCS therapy for patients with DPN.

• At the two-year follow up, 81% of patients reported a 50% or greater reduction in pain.
• High level of improvement and treatment satisfaction was reported with PGIC (Patient Global Impression of Change) measure, up to three-year follow-up.

Clinical outcomes using FAST Therapy (Fast-Acting Sub-Perception-Based Therapy)

Multiple prospective and real-world studies from Europe and the United States demonstrated significant and sustained pain relief using the Boston Scientific proprietary FAST Therapy, designed to provide immediate paresthesia-free pain relief.

• At approximately one-year follow-up across these ongoing studies, consistent improvement has been observed, with at least 88% of SCS patients reporting 50% or greater pain relief.
• Evaluation of 311 enrolled patients is ongoing.

For more information about the impact of chronic pain and interventional treatment options, visit Pain.com.

About Boston Scientific
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world.  As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.  Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. For more information, visit www.bostonscientific.com and connect on Twitter and LinkedIn.

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Media Relations
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