Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced that Nevro’s HFX 10 kHz Therapy is the only form of spinal cord stimulation (SCS) therapy to be referenced by the American Association of Clinical Endocrinology (AACE) in its 2022 Diabetes Clinical Practice Guideline to treat painful diabetic neuropathy (PDN).
Based on results from Nevro’s landmark SENZA-PDN randomized controlled study, the AACE guideline states that high frequency (e.g., 10 kHz) spinal cord stimulation is a nonpharmacological approach that may be effective in persons with painful diabetic peripheral neuropathy that failed at least one medication.¹,² The treatment algorithm in the guideline also includes a referral to a pain physician for assessment if medical therapy has failed.
“For a clinician specializing in providing care for patients with diabetes, helping those with intractable pain of peripheral diabetic neuropathy is probably the most frustrating aspect of my practice,” commented Dr. George Grunberger, Chairman of the Grunberger Diabetes Institute in Bloomfield Hills, Michigan and Past President of the American Association of Clinical Endocrinologists. “There is a dearth of effective medications approved by the FDA for its management, and none of these are disease modifying. Medications which are being used are in many cases ineffective and/or associated with side effects. Of course, their use also necessitates life-long adherence. It was thus welcome news when the FDA approved high-frequency spinal cord stimulation for the management of PDN and also encouraging to see that its use for these patients is listed in the latest update of the AACE guideline for comprehensive care planning for diabetes.”
“This is a very positive endorsement of our proprietary, high-frequency 10 kHz Therapy by an important community of health care providers specializing in endocrinology, diabetes, and metabolic disorders,” stated D. Keith Grossman, Chairman, CEO and President of Nevro. “Based on our strong and growing body of published, peer-reviewed clinical trial data that demonstrated twice the patient responder rate, twice the pain relief and the only study to demonstrate neurologic improvements, we believe that our HFX solution is uniquely positioned to provide relief to the thousands of patients suffering from PDN.”
The 2022 guideline update synthesizes thousands of articles to provide health care professionals with the latest evidence-based information on the total care of diabetes.