BY QUINN PHILLIPS | JANUARY 1, 1970
The U.S. Food and Drug Administration (FDA) has approved a neurostimulation device from DyAnsys, Inc., to treat pain related to diabetic peripheral neuropathy, according to a press release from the company.
The newly approved device, called First Relief, is what’s known as a PENS (percutaneous electrical neurostimulation) 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 with pain relief. 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 “chronic, intractable pain from diabetic peripheral neuropathy.”
The latest approval is based on a study that compared First Relief with both a placebo (inactive device) and another previously approved neurostimulation device. As noted in the press release, this study involved 63 participants ages 30 to 74. Participants were randomly assigned to undergo one of the treatments for a total of 16 weeks, with the device worn for continuous periods lasting two weeks 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, as measured by what’s known as the Visual Analog Scale — which asks participants to rate their pain using a visual device. Other measurements looked at participants’ vibration perception threshold (VPT), insomnia severity, overall neuropathy limitations, and anxiety.
First Relief linked to significant reductions in pain intensity
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 a low-level electrical current over several days. (Image courtesy of DyAnsys.)
Participants who were treated with First Relief saw a significant reduction in their pain intensity from the beginning to the end of the study period. This improvement lasted throughout the study’s 90-day follow-up period, indicating that they experienced long-term pain relief. Each of the other measurements also improved during the study period, with participants sleeping better and experiencing less anxiety as their pain was reduced. No adverse events were reported by any participants.
“We are excited to have the FDA clearance of First Relief so that this device, which has been proven effective, can now be used to treat patients who have been experiencing pain related to diabetic neuropathy,” said Srini Nageshwar, CEO of DyAnsys, in the press release. “First Relief offers a significant treatment option without drugs or narcotics.”
As noted in an article on the latest approval at Fierce Biotech, the First Relief device uses three tiny needles that enter the skin at the site of application. The same basic technology is used on a device by DyAnsys 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 previously been approved by the FDA, one advantage of First Relief is that it doesn’t require surgical implantation — making it easier to start using the device, without any risk of infection or other risks related to the implantation procedure. If you’re 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 that is currently available.
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