The Food and Drug Administration (FDA) has cleared First Relief, a percutaneous electrical neurostimulation (PENS) device, for multiple treatments up to 56 days for symptomatic relief of chronic, intractable pain from diabetic peripheral neuropathy.
First Relief is placed behind the ear to target the associated cranial and occipital nerves. The device delivers continuous pulses of low level electrical current over several days. The approval was based on data from a single center, randomized, controlled, double-blind, prospective study (ClinicalTrials.gov Identifier: NCT03540446) that evaluated the effectiveness of First Relief in 63 patients 30 to 74 years of age with diabetic peripheral neuropathy.
Patients were randomly assigned to 1 of 3 groups: First Relief, sham device, or an already FDA-cleared device. The devices were applied on a biweekly basis for 16 weeks.
The primary endpoint was pain intensity measured through Visual Analog Scale (VAS) score. The secondary endpoints included vibration perception threshold value, insomnia severity index, overall neuropathy limitations scale, and Hamilton rating scale for anxiety.
Results showed that patients treated with First Relief experienced a significant reduction in VAS pain score from the start of treatment to the end; these improvements continued throughout the 90-day follow-up, suggesting that the device could provide long term improvement in neuropathic pain. Significant improvements were also observed on all secondary endpoints. There were no complications or adverse events reported during the study.
“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 CEO Srini Nageshwar. “First Relief offers a significant treatment option without drugs or narcotics.”
FDA clears DyAnsys neurostimulation device first relief to treat diabetic neuropathic pain. News release. DyAnsys Inc. Accessed July 14, 2022. https://www.prnewswire.com/news-releases/fda-clears-dyansys-neurostimulation-device-first-relief-to-treat-diabetic-neuropathic-pain-301586766.html