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FDA Clears Wearable App Device for Migraine

Nerivio Migra patch

Nerivio Migra patch (Theranica Bioelectronics)

28 May 2019. The Food and Drug Administration authorized a wearable nerve-stimulation device controlled by a mobile app to treat acute migraine headaches. The agency granted Theranica Bioelectronics, a 3 year-old company in Netanya, Israel, a de novo request, clearance to market a new type of medical device, for the company’s Nerivio Migra system.

Migraine is a neurological syndrome causing severe headaches along with nausea, vomiting, and extreme sensitivity to light and sound. In some cases, migraines are preceded by warning episodes called aura including flashes of light, blind spots, or tingling in arms and legs. The web site Migraine.com estimates 37 million people in the U.S. suffer from migraines, and cites World Health Organization data indicating migraines affect 18 percent of American women and 7 percent of men.

The Nerivio Migra system consists of a patch worn on the upper arm, with electrodes sending out neuromodulation pulses that electronically stimulate C-fiber nerves and block pain signals from reaching the brain. C-fiber nerves are one of the pain pathways in the nervous system. When a migraine occurs, the individual straps on the Nerivio Migra patch and activates nerve stimulation through an accompanying smartphone app for about 20 minutes. The app’s software also checks for proper placement of the patch, monitors the neuromodulation session, and can link to health care providers that need to be alerted.

A clinical trial enrolling 296 individuals in the U.S. and Israel with multiple migraines per month shows the device relieved migraine pain and associated systems in more participants than a sham device, as well as providing pain relief for longer periods. In March 2017, Science & Enterprise reported on an earlier clinical trial of the device that showed reductions in the amount of pain experienced by people with migraines. That study also tested the system against a sham device.

FDA cleared the Nerivio Migra system for people age 18 and over experiencing acute migraine headaches, either with or without aura. The device is not authorized to treat chronic migraines. While the system requires a prescription, it can be used at home without supervision at the onset of a migraine.

The agency classifies Nerivio Migra as a class 2 device, indicating moderate medical risk. Since the the device is the first of its kind reviewed by FDA for migraine — a neuromodulation device attached to a limb or trunk of the body rather than head or neck —  Nerivio Migra qualified for a de novo classification. FDA will use the Nerivio Migra as a comparison device for future pre-market reviews of similar systems.

While FDA authorized the company to market Nerivio Migra, the agency requires extra controls and further performance testing to verify its neuromodulatiooon signals and monitor for possible adverse reactions, interference with other electronic devices, malfunctioning equipment or software, and user errors. The agency also spells out labeling and documentation requirements for the system.

Theranica plans to introduce Nerivio Migra to the American market later this year, and is developing systems to treat other pain experiences. Alon Ironi, CEO and co-founder of Theranica, says in a company statement, “we remain committed to continuing our clinical development, expanding the use of remote electrical neuromodulation therapy for additional indications. We have identified at least 7 different painful conditions that may be relieved by this non-invasive, drug-free technology after appropriate clinical development.”

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