The U.S. Food and Drug Administration (FDA) has approved an implantable device used to treat diabetic peripheral neuropathy, which will be marketed by its manufacturer, Nevro, as HFX for PDN (painful diabetic neuropathy), according to a press release from the company.
As we noted in a recent news item, initial results from the first six months of a clinical trial of the HFX device were published in April 2021 in the journal JAMA Neurology, and updated results after 12 months of the trial were recently presented virtually at the 81st Scientific Sessions of the American Diabetes Association. In both the first and second six-month periods of the trial, the spinal cord stimulation treatment — in which a surgically implanted device emits high-frequency sound waves — was found to drastically outperform conventional treatment for peripheral neuropathy. In the first six months, for example, 79% of people using HFX saw at least a 50% reduction in their pain score, compared with just 5% of people who received only conventional treatment for their neuropathy. For the second six months of the trial, in which a larger group of participants received the treatment, 86% of participants saw at least a 50% reduction in their pain score.
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Not everyone with peripheral neuropathy — a common long-term complication of diabetes — experiences severe or frequent pain. Other symptoms of peripheral neuropathy, which usually affects the hands, arms, feet, and legs, can include numbness, tingling, or prickling or burning sensations. For people who experience frequent or severe pain due to peripheral neuropathy, there are only limited treatment options that have been shown to be effective. Some people find that applying a topical cream containing capsaicin — a compound derived from chili peppers that gives them their “hotness” — offers relief, and the FDA approved Qutenza, a patch containing capsaicin that is applied by a doctor and worn for up to three months, last year.
Due to the risks that come with surgical implantation, including infection, HFX may be reserved for consistently or severely painful cases of peripheral neuropathy. In these situations, it is likely to be greeted by doctors and patients alike as a potentially life-altering treatment option.
“The substantial pain relief and improved quality of life demonstrates that [HFX] can safely and effectively treat this patient population,” said study author Erika A. Petersen, MD, director of functional and restorative neurosurgery at the University of Arkansas for Medical Sciences. “This approval will have far-reaching impact on the lives of PDN patients.”
The clinical trial of HFX is ongoing, and will continue to follow participants for a total period of 24 months. The latest study results, covering the first 12 months, are expected to be published in a peer-reviewed scientific journal in the coming months. Nevro has announced that it will begin to commercially launch HFX in the United States immediately, with phased launch plans in Britain, Germany, and Australia followed by further expansion in 2022.