USA – FDA expands approval for migraine neuromodulation device

The Food and Drug Administration (FDA) has expanded the approval of Nerivio® (Theranica) to include acute treatment of migraine with or without aura in patients aged 18 years and older with chronic migraine. Previously, the device had only been approved in those with episodic migraine.

Nerivio is a wireless remote electrical neuromodulation (REN) device designed to be self-applied to the upper arm. The prescription device uses electrical pulses to stimulate C and Aδ nociceptive sensory fibers of the upper arm to activate the brain’s conditioned pain modulation response to treat pain and migraine symptoms. It is controlled by a smartphone application that allows the user to adjust the stimulation intensity, monitor the duration of treatment, and pause or stop the stimulation. The app also includes a migraine diary, which can be shared between patients and health care professionals…