Nevro Announces Consensus Statement Supporting High-Frequency (10 kHz) Spinal Cord Stimulation Therapy for Refractory Painful Diabetic Neuropathy

2024-02-01

临床研究上市批准

Experts in diabetes, pain and health services from the Worldwide Initiative for Diabetes Education recommend spinal cord stimulation when symptoms aren't responsive to first- or second-line therapies

REDWOOD CITY, Calif., Feb. 1, 2024 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced the publication of a consensus statement summarizing recommendations based on outcomes from a December 2022 global, interdisciplinary panel, "Advances in the Management of Painful Diabetic Neuropathy," at the Worldwide Initiative for Diabetes Education (WorldWIDE Diabetes) Virtual Global Summit. The statement, published in Diabetes Research and Clinical Practice, recommends spinal cord stimulation (SCS) therapy – and, particularly, high-frequency (10 kHz) SCS – to treat refractory painful diabetic neuropathy (PDN) symptoms that aren't adequately addressed by first- and second-line treatments.

"These guidelines represent an important validation of Nevro HFX for PDN as an effective therapy that can support patients seeking relief from their refractory PDN symptoms," said David Caraway, MD, chief medical officer at Nevro. "The publication of these guidelines would not have been possible without the dedication of the investigators and patients who participated in the SENZA-PDN randomized controlled trial (RCT), the largest RCT studying SCS for PDN. This data has been instrumental in demonstrating the value of high-frequency (10 kHz) SCS for this challenging patient population."

"Healthcare providers have long sought a viable, long-term solution that can provide relief for people suffering from PDN. Through the SENZA-PDN RCT, I observed how high-frequency SCS can offer pain relief, in addition to improvements in quality of life, sleep and neurological function," said SENZA-PDN lead principal investigator Dr. Erika Petersen, professor of neurosurgery and director of functional and restorative neurosurgery at the University of Arkansas for Medical Sciences. "I'm encouraged to see this therapy gaining further recognition from global experts in PDN management and grateful to my co-investigators for their partnership in our research."

Globally, the number of people with diabetes has quadrupled in the last two decades.1 More than 50% of people with type 2 diabetes eventually develop diabetic neuropathy2, and are at risk of developing PDN. Symptoms of PDN can have a significant impact on quality of life. These symptoms include numbness, tingling/paresthesia, loss of protective sensation, impaired balance, and reduced response to sensory stimuli.3 Patients typically manage this complication with oral pain medications, but the efficacy of these medications is relatively low and can result in intolerable side effects for patients.4 As a result, people with PDN suffer significantly reduced health-related quality of life (HRQoL), impaired functionality, and other comorbidities like sleep disorders, depression, and anxiety.5

"Nevro is the only company to offer a high-frequency (10 kHz) paresthesia-free SCS system that is FDA-approved to treat PDN. This latest consensus document provides confirmation from multidisciplinary, international PDN management experts that the unique technology behind our 10kHz Therapy offers the greatest efficacy in reducing pain and restoring neurologic function for people with PDN," said Kevin Thornal, Nevro's president and chief executive officer. "We extend our gratitude to the WorldWIDE Diabetes panelists who authored this statement for their thoughtful, evidence-based approach to reviewing available PDN therapies when making their recommendations."

In addition to this latest consensus statement, SCS or high-frequency (10 kHz) SCS has also been recommended by the:

American Diabetes Association (ADA)

German Diabetes Association Diabetes Association

German Interdisciplinary Association for Pain Therapy

2021 international consensus document for diabetic neuropathy

American Association of Clinical Endocrinologists (AACE), which specifically recommends high-frequency SCS for PDN

To learn more about Nevro's 10 kHz Therapy™ for PDN visit: www.nevro.com.

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About Nevro

Headquartered in Redwood City, California, Nevro is a global medical device company focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The company started with a simple mission to help more patients suffering from debilitating pain and developed its proprietary 10 kHz Therapy™, an evidence-based, non-pharmacologic innovation that has impacted the lives of more than 100,000 patients globally. Nevro's comprehensive HFX™ spinal cord stimulation (SCS) platform includes the Senza® SCS system and support services for the treatment of chronic pain of the trunk and limb and painful diabetic neuropathy.

Nevro recently added a minimally invasive treatment option for patients suffering from chronic sacroiliac joint ("SI joint") pain and now provides the most comprehensive portfolio of products in the SI joint fusion space, designed to meet the preferences of physicians and varying patient needs in order to improve outcomes and quality of life for patients.

Senza®, Senza II®, Senza Omnia®, and HFX iQ™ are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy™. Nevro's unique support services provide every patient with HFX Coach™ support throughout their pain relief journey and every physician with HFX Cloud™ insights for enhanced patient and practice management.

SENZA, SENZA II, SENZA OMNIA, OMNIA, HF10, the HF10 logo, 10 kHz Therapy, HFX, the HFX logo, HFX iQ, the HFX iQ logo, HFX Algorithm, HFX CONNECT, the HFX Connect logo, HFX ACCESS, the HFX Access logo, HFX COACH, the HFX Coach logo, HFX CLOUD, the HFX Cloud logo, RELIEF MULTIPLIED, the X logo, NEVRO, and the NEVRO logo are trademarks or registered trademarks of Nevro Corp. Patents covering Senza HFX iQ and other Nevro products are listed at Nevro.com/patents.

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1 World Health Organization. (‎2016)‎. Global report on diabetes. World Health Organization. https://apps-who-int.libproxy1.nus.edu.sg/iris/handle/10665/204871

2 Pop-Busui R, Ang L, Boulton AJM, et al. Diagnosis and treatment of painful diabetic peripheral neuropathy. Arlington (VA): American Diabetes Association 2022. https://www-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/pubmed/35544662.

3 Pop-Busui R, Ang L, Boulton AJM, Feldman EL, Marcus RL, Mizokami-Stout K, et al. Diagnosis and Treatment of Painful Diabetic Peripheral Neuropathy. Arlington (VA): American Diabetes Association; 2022.

4 Yang, M., Qian, C., & Liu, Y. (2015). Suboptimal Treatment of Diabetic Peripheral Neuropathic Pain in the United States. Pain medicine (Malden, Mass.), 16(11), 2075–2083.

5 Alleman, C. J., Westerhout, K. Y., Hensen, M., Chambers, C., Stoker, M., Long, S., & van Nooten, F. E. (2015). Humanistic and economic burden of painful diabetic peripheral neuropathy in Europe: A review of the literature. Diabetes research and clinical practice, 109(2), 215–225.

SOURCE Nevro Corp.