Express significantly improves chronic diabetic pain, FDA approves spinal cord electrical stimulation system

▎ WuXi AppTec content team editor July 19, 2021, Nevro announced that its proprietary 10 kHZ spinal cord stimulation (SCS) "Senza" system has been approved by the US FDA for the treatment of painful diabetic neuropathy (PDN).
) Chronic pain caused by
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The press release states that this is the first spinal cord stimulation system approved by the FDA to use PDN as an indication
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The company will launch a PDN treatment-related product called "HFX" based on this approval
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HFX represents a comprehensive treatment plan that includes the Senza Spinal Cord Stimulation System and support services for the treatment of chronic pain
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The current clinical trial data show that compared with traditional medical management solutions, HFX can relieve the pain of PDN patients by an average of 76%
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According to estimates by the World Health Organization (WHO), there are currently approximately 422 million adults with diabetes worldwide, and the prevalence (8.
5%) has almost doubled in 40 years
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Diabetes can cause systemic damage and have a profound impact on health-related quality of life, and may even be life-threatening
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PDN is a common diabetic complication, and about 20% of diabetic patients will develop PDN
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This is a progressive, potentially debilitating, chronic neuropathic pain disorder characterized by pain and other insensitivity, including numbness, burning, or tingling
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In April 2021, the randomized controlled SENZA-PDN trial of Senza Spinal Cord Stimulation System showed that it can safely provide effective treatment for patients with refractory PDN
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Even when the electrical stimulation frequency of 10 kHZ is used, it can provide PDN patients (n=216) with clinically significant pain relief for more than 6 months and an improvement in health-related quality of life
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The results of the test have been published in JAMA Neurology
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In addition, at the 81st Scientific Meeting of the American Diabetes Association (ADA) held in June 2021, Nevro announced the trial’s 12-month follow-up results and 6-month crossover patient data
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The company also plans to publish these results in a peer-reviewed journal, and the trial subjects will continue to receive a 24-month follow-up
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▲Senza Omnia system developed by Nervo (picture source: reference [1]) "The US FDA's approval provides a way for PDN patients who are struggling with debilitating pain and cannot find relief through existing therapies.
A proven and breakthrough new spinal cord stimulation treatment option
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” said Dr.
D.
Keith Grossman, Chairman, CEO and President of Nevro
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Reference: [1] Nevro Announces FDA Approval of its 10 kHz High Frequency Spinal Cord Stimulation Therapy for Treatment of Chronic Pain Associated with Painful Diabetic Neuropathy (PDN).
Retrieved July 19, 2021, from https://nevro.
com/English /us/investors/investor-news/investor-news-details/2021/Nevro-Announces-FDA-Approval-of-its-10-kHz-High-Frequency-Spinal-Cord-Stimulation-Therapy-for-Treatment-of -Chronic-Pain-Associated-with-Painful-Diabetic-Neuropathy-PDN/default.
aspx[2] Petersen, E.
(2020).
Abstract #862608: Neuromodulation For Treatment of Painful Diabetic Neuropathy – A Multicenter Randomized Controlled Trial Comparing 10 Khz Spinal Cord Stimulation to Conventional Medical Management.
Endocrine Practice, 26, 159–160.
https://doi.
org/10.
1016/s1530-891x(20)39871-2 Note: This article aims to introduce medical and health research progress, not treatment Program recommendation
.

If you need guidance on treatment plans, please go to a regular hospital for treatment
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