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.
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