FDA approval for neurostimulation device to treat diabetic neuropathic pain

pharmafile | July 15, 2022 | News story | Medical Communications  

DyAnsys has received FDA approval for its First Relief device, a wearable device monitoring pulses of a low-level electrical current over several days, made for diabetic peripheral neuropathy pain. The device is intended for multiple treatments for up to 56 days.

First Relief is a percutaneous electrical neurostimulation (PENS) device, intended for multiple treatments 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 testing First Relief against a placebo, and another device previously cleared by the FDA, and was conducted in the Jeevak Multispeciality Hospital in Warangal, India. This hospital is renowned for the treatment of diabetes.

In the trial, pain intensity was determined by the Visual Analog Scale (VAS) score, as the primary efficacy endpoint.

The single centre, three arm, randomised, controlled, parallel assignment, double blinded, prospective study involved 63 patients aged 30 to 74 years. The First Relief device was administered every two weeks for 16 weeks.

According to VAS pain score analysis, the pain score of patients being treated with the First Relief device was significantly decreased from the start of the treatment to the end, with improvement remaining over the 90-day follow-up, indicating that the therapy improved neuropathic pain in the long term, rather than providing a temporary relief.

Neuropathic pain is caused by damage or injury to the nerves that transfer information between the brain and spinal cord from the skin, muscles, and other parts of the body.  It is often described as a shooting or burning pain, with affected areas frequently being sensitive to the touch in patients.

Ana Ovey

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