FDA Clears Percutaneous Electric Neurostimulation for Diabetic Peripheral Neuropathy Treatment

The Food and Drug Administration (FDA) cleared a wearable percutaneous electrical neurostimulation (PENS) device (First Relief, Dyansys, Palo Alto, CA) for chronic pain from diabetic peripheral neuropathy. The device is placed on the ear to release continuous pulses of a low-level electrical current over several days.

"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 DyAnsys chief executive officer Srini Nageshwar. "First Relief offers a significant treatment option without drugs or narcotics."

The PENS device showed a long-term improvement in neuropathic pain in individuals with chronic pain when compared with placebo and a previously FDA cleared device in a study. The PENS device was measured in pain intensity through Visual Analog Scale (VAS), vibration perception threshold (VPT) value, insomnia severity index (ISI), overall neuropathy limitations scale (ONLS), and Hamilton rating scale for anxiety.

The prospective study was conducted at Jeevak Multispeciality Hospital in Warangal, India, enrolled 63 participants from age 30 to 74 who had the devices applied biweekly for 16 weeks. 

On the VAS, significant pain reduction was scored by the participants who were treated with the PENS device from start to finish with treatment. This improvement continued to the 90-day follow-up. The VPT, Insomnia, ONLS and HAM scores also showed similar improvements in pain relief as well as significant improvement in sleep and mood.

There were no adverse events observed during the study period.