FDA Clears novel Neurostimulation Device to treat Diabetic Neuropathic Pain
The US Food and Drug Administration has cleared a percutaneous electrical neurostimulation (PENS) device for symptomatic relief of chronic, intractable pain from diabetic peripheral neuropathy.
"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."
The approval was based on a study that tested First Relief against a placebo and another device previously cleared by the US Food and Drug Administration.
The study was conducted at the Jeevak Multispeciality Hospital in Warangal, India, renowned for the treatment of diabetes. The single center, three-arm, randomized, controlled, parallel assignment, double blinded, prospective study involved 63 patients age 30 to 74.
The devices were applied on a bi-weekly basis for 16 weeks. The primary efficacy endpoint was pain intensity measured through Visual Analog Scale (VAS) score and the secondary efficacy endpoints are vibration perception threshold (VPT) value, insomnia severity index (ISI), overall neuropathy limitations scale (ONLS), Hamilton rating scale for anxiety.
The VAS pain score analysis showed a significant reduction in the pain score of patients being treated with First Relief from start of the treatment to the end. This improvement persisted throughout the 90-day follow-up, suggesting that the treatment was a long-term improvement in neuropathic pain and not a short-term improvement.
The secondary outcome measures (VPT, Insomnia, ONLS and HAM) also showed similar improvements to the pain score, showing significant improvement in sleep and mood as the neuropathic pain decreased.
Reference:
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
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