FDA Approves Implanted Spinal Cord Stimulator for Chronic Painful Diabetic Neuropathy

The Food and Drug Administration (FDA) granted premarket approval to an implanted spinal cord stimulator (Senza System; Nevro, Redwood City, CA) for treatment of chronic pain associated with painful diabetic neuropathy (PDN). As published in JAMA Neurology, after 6 months of treatment, 79% of those treated with neurostimulation plus conventional management experienced had at least a 50% reduction in pain with no worsening of neurologic symptoms. Of those treated with conventional management alone, only 5% had a 50% pain reduction (P<.001). The mean pain reduction in people who had neurostimulation added to treatment was 79%. 

"This FDA approval marks a capstone achievement that demonstrates the strength of our clinical data and provides a proven, new breakthrough SCS treatment option for PDN patients who are struggling with debilitating pain and who are unable to find relief with currently available pharmacologic options," said D. Keith Grossman, chairman, chief executive officer and president of Nevro.  "We are thrilled that we can now begin commercial launch activities in the US and believe this new indication will be an important driver of the long-term growth of our business for years to come."

Mr. Grossman continued, "We would like to thank lead principal investigator Dr. Erika Petersen and the entire team of clinical trial investigators and their patients for their study participation and ongoing partnership, without whom this approval would not have been possible."

"The substantial pain relief and improved quality of life demonstrates that 10 kHz Therapy can safely and effectively treat this patient population," stated Dr. Erika Petersen, professor of Neurosurgery, director of Functional and Restorative Neurosurgery at the University of Arkansas for Medical Sciences, and lead investigator of the SENZA-PDN study.  "I'm grateful to my coinvestigators and the patients who participated in this study, as the results and this approval will have far-reaching impact on the lives of PDN patients."

"Diabetic neuropathy is one of the most prevalent and debilitating, chronic complication of diabetes, and for years, PDN patients have struggled with a lack of effective treatment options when conventional medications fail or are not tolerated," commented Dr. Frances Broyles, medical director of Diabetes/Endocrinology and Nutrition at Swedish Health Services in Seattle, Washington. "The ability to now offer Nevro's proven 10 kHz Therapy, which may enable discontinuation of long-term drug therapy and eliminate unwanted drug side effects, is a welcome addition as a treatment option for my PDN patients dealing with this challenging condition. My personal practice experience with the Nevro 10 kHz Therapy was nothing short of life changing for the patient."