Source: Siyu MedTech; Editor: Liu XinyiReprint Requirements: Please indicate the source of the article at the beginning of the text, and it can be reprinted directly.
On January 20, 2024, Boston Scientific (NYSE: BSX) announced that trials have proven the use of its subsidiary'sWaveWriter Alpha™ Spinal Cord Stimulation (SCS) System for Non-Surgical Back Pain (NSBP) Provides Sustained Pain Relief。
This trial, named SOLIS, had its data shared by Boston Scientific at the annual meeting of the North American Neuromodulation Society (NANS) held in Las Vegas from January 18 to 21, 2024.
# SOLIS Trial Data
The SOLIS trial was a randomized controlled trial with 128 participants, utilizing the WaveWriter system and the WaveWriter Alpha™ SCS system. The WaveWriter Alpha™ SCS system received FDA approval in December 2020. It is capable of substituting pain with a tingling sensation, as well as employing imperceptible stimulation to block pain signals. Additionally, it is equipped with Boston Scientific's FAST™ (Fast Acting Stimulation Therapy) therapy, which aims to provide immediate pain relief without the tingling sensation.
WaveWriter Alpha™ SCS SystemThe study met its primary endpoint, with the main data as follows:：- At the primary observation time point of the study, 90% of patients using the WaveWriter system reported significant pain reduction, with a decrease of 50% or more.Moreover, the dosage of opioid medications for these patients has not increased. In contrast, only 8% of patients receiving conventional medical management (CMM) alone showed similar effects (p<0.0001).
- One year later, 84% of patients using the WaveWriter system reported significant pain reduction of 50% or more. Meanwhile, these patients also indicated a sustained improvement in their ability to perform daily living activities. According to the Oswestry Disability Index (ODI) assessment, the average ODI score of these patients decreased by 25 points.
- Patients in the CMM group who later chose to receive SCS therapy showed significant improvements in pain and dysfunction after one year, consistent with the performance of patients in the SCS group. TheseSubjects who received cross-treatment reported an 85% reduction in pain by 50% or more, with an average decrease of 30 points in the ODI index.。
Regarding this, Jim Cassidy, President of Boston Scientific's Neuromodulation Division, stated: "The SOLIS study data indicate that when standard care alone is insufficient, early intervention with effective pain therapies is necessary."In addition to this experimental data, Boston Scientific also announced the clinical efficacy of SCS therapy for treating painful diabetic peripheral neuropathy (DPN) and the use of FAST™ therapy.This global multicenter study prospectively enrolled 43 patients. The data showed that at all long-term time points, the patients experienced significant pain reduction, and a high proportion reported improved conditions.The specific data is as follows:- During the two-year follow-up, 81% of patients reported a pain reduction of 50% or more;
- According to the Patient Global Impression of Change (PGIC) scale, a high proportion of patients reported improvement in pain and satisfaction with treatment outcomes during a three-year follow-up.
DPN is a complication of diabetes, with insidious onset, affecting more than 50% of patients. It progresses chronically and becomes increasingly severe. In the early stage, it is characterized by limb pain and numbness, and in the late stage, it can lead to foot ulcers and even amputation.Diabetic foot is a typical manifestation of diabetic peripheral neuropathy. In China, the incidence rate of diabetic foot in diabetic patients over 50 years old is as high as 8.1%. The mortality rate of diabetic foot amputees is up to 22%.The pain mechanism of DPN involves nerve fiber damage, inflammation, and oxidative stress triggered by hyperglycemia, leading to abnormal nerve signal transmission and central nervous system involvement, causing patients to experience persistent hypersensitivity and pain. SCS, as a cutting-edge treatment for PDPN, offers a new therapy that effectively alleviates pain.Data on the FAST™ therapy come from multiple prospective and real-world studies conducted in Europe and the United States.The specific data are as follows:- Follow-up data of about one year for these studies show that patients' pain has continued to improve. At least 80% of patients using SCS therapy reported a reduction in pain of 50% or more;
- The evaluation of 311 subjects is still ongoing.
# About Boston ScientificBoston Scientific was founded in 1979, with its headquarters in Natick, Massachusetts, USA. It is a global leading medical technology company. In 1997, Boston Scientific entered China, establishing branch offices and research centers in Beijing, Shanghai, and Guangzhou. The company's headquarters in China is located in Shanghai. In May 1992, Boston Scientific was successfully listed on the New York Stock Exchange.Currently, Boston Scientific Corporation's business is divided intoEndoscope、Urinary、Neuromodulation、MedSurg、Heart Disease、Peripheral InterventionAndCardiovascular。On October 26, 2023, Boston Scientific announced its financial report for the third quarter of 2023. The report shows,The company's net sales in the third quarter reached $3.527 billion.Compared with the same period last year, the reported growth rate was 11.2%, the operational growth rate was 11.1%, and the organic growth rate was 10.2%.By business segment, Boston Scientific's MedSurg division grew 10.6% on a reported basis, 10.0% on an operational basis, and 9.4% organically.Urology business revenue was $483 million,Neuromodulation Business Revenue of $229 Million; while the Cardiovascular segment grew 11.6% over the reported basis, 11.7% over the operational basis, and 10.6% in organic growth.
