FDA OKs wearable neurostimulator from DyAnsys to treat pain from diabetic nerve damage

In the wake of the FDA’s approval of Medtronic’s implanted spinal cord stimulators to treat pain associated with diabetic peripheral neuropathy, DyAnsys has secured an agency nod of its own for a significantly less invasive approach.

Diabetic neuropathy is a form of nerve damage that may occur in people with diabetes, linked to heightened blood sugar levels. It most commonly affects the nerves in the legs and feet and can cause pain ranging from a mild tingling or numbness to a debilitating stabbing feeling.

Though most commonly treated with drugs, Medtronic’s January approval made its Intellis and Vanta neurostimulators available to people experiencing painful diabetic neuropathy. Those devices are implanted in the space between the vertebral canal and the spinal cord, where they send out electrical pulses to block pain signals from reaching the brain.

DyAnsys’ First Relief system relies on a similar mechanism but is simply adhered behind the ear, eliminating the need for an implantation procedure.

The First Relief device features three small, acupuncturelike needles that reach through the skin behind the ear to access the nervous system. Once in place, the device continuously emits low-level electrical pulses over the course of several days at a time; the FDA cleared the system for repeated treatments spanning up to eight weeks.

Similar technology is used in DyAnsys’ Drug Relief system, which was cleared in 2018 to help lessen the symptoms of opioid withdrawal including anxiety, agitation, depression, nausea, craving and more.

The latest clearance came after a study of the device resulted in significant reductions in the pain scores of patients between the ages of 30 and 74 with painful diabetic neuropathy. According to DyAnsys, those improvements lasted for at least 90 days after the study period was over, indicating that the neurostimulation treatment could lead to permanent pain relief.

Participants who underwent treatment with the First Relief device also reported significant improvements in their sleep and mood, correlating with the decreases in their pain symptoms. No adverse reactions or complications were linked to the device during the study.

As the opioid crisis rages on, the FDA has ramped up its reviews of tech-based alternatives to pain relief. Late last year, it doled out its first approval for a virtual reality program to treat lower back pain, issuing the groundbreaking green light to AppliedVR’s EaseVRx device.

In May of this year, the agency cleared its first non-drug fibromyalgia treatment. That nod went to NeuroMetrix and its Quell device, an electrode-laden sleeve that wraps around the upper leg to stimulate the sensory nerves there.