DyAnsys neurostimulation device approved for neuropathic pain

The US Food and Drug Administration (FDA) has approved a neurostimulation device from DyAnsys, Inc., to treat pain related to diabetic peripheral neuropathy, according to a company news release.

The newly approved device, called First Relief, is what is known as a PENS (percutaneous electrical nerve stimulation) device. That means it’s worn on the surface of the skin, in this case behind the ear, and delivers a low-level electrical current to help relieve pain. First Relief can provide continuous pain relief for several days at a time, and is approved for a total of up to 56 days of treatment for the “chronic, intractable pain of diabetic peripheral neuropathy.”

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The latest approval is based on a study that compared First Relief to a placebo (inactive device) and another previously approved neurostimulation device. As stated in the press release, this study involved 63 participants aged 30 to 74 years. Participants were randomized to undergo one of the treatments for a total of 16 weeks, with the device worn for continuous two-week periods during that time. Neither the participants nor the researchers knew, at the time, which device a participant was wearing.

The main outcome the researchers were interested in was pain intensity, measured by what is known as the visual analog scale, which asks participants to rate their pain using a visual device. Other measures looked at participants’ vibration perception threshold (VPT), ​​severity of insomnia, general neuropathy limitations, and anxiety.

First Relief linked to significant reductions in pain intensity

DyAnsys First Relief Neurostimulation Device
The First Relief Percutaneous Neurostimulation Device can be used to treat pain related to diabetic neuropathy. It is applied behind the ear and delivers continuous pulses of low-level electrical current for several days. (Image courtesy of DyAnsys.)

Participants who were treated with First Relief saw a significant reduction in pain intensity from the beginning to the end of the study period. This improvement lasted throughout the 90-day follow-up period of the study, indicating that they experienced long-term pain relief. Each of the other measures also improved over the study period, with participants sleeping better and experiencing less anxiety as pain was reduced. No participants reported adverse events.

“We are excited to have First Relief FDA approval so that this proven device can now be used to treat patients who have been experiencing pain related to diabetic neuropathy,” said Srini Nageshwar, Director DyAnsys executive, in the press release “First Relief offers an important treatment option without drugs or narcotics”.

As noted in an article about Fierce Biotech’s latest approval, the First Relief device uses three tiny needles that are inserted into the skin at the application site. The same basic technology is used in a DyAnsys device called the Drug Relief system, which is used to treat opioid withdrawal and was approved by the FDA in 2018.

While other neurostimulation devices have been previously approved by the FDA, an advantage of First Relief is that it does not require surgical implantation, making it easy to get started with the device, without any risk of infection or other risks related to the implantation procedure. If you are a candidate for a neurostimulation device to treat your peripheral neuropathy, ask your health care provider about the risks and benefits of each type of device currently available.

Do you want to know more about neuropathy? Read “Dealing with Painful Neuropathy,” “Diabetic Neuropathy,” and “Managing Neuropathic Pain.”

Originally published on August 2, 2022

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