FDA has approved Nerivio Migra by Theranica a complete solution Migraine patient. It is a first smartphone-controlled acute migraine-relief wearable device available in the market.
The approval came through a De Nova pathway. The approval was due to the results of a prospective, randomized, double-blind, placebo-controlled, multi-centre pivotal study, where 252 patients from 12 clinics used the non-invasive wearable to treat their migraine attacks.
It uses advanced electroceuticals for migraine and other pain disorders and can be controlled remotely.
As per company press release, “The clinical data of this innovative therapeutic device is of very high quality,” commented Professor Messoud Ashina, Danish Headache Center, president-elect of the International Headache Society. “It indicates that the device can provide patients with significant relief of pain and other migraine symptoms without the side effects presented by drugs.”
“The results of the study demonstrate a high efficacy ratio for single as well as multiple attacks, both at two and 48 hours after treatment,” explained Dr. Grosberg, who was a co-author of an article describing the study, released earlier this month in Headache: The Journal of Head and Face Pain published by Wiley Periodicals, Inc. on behalf of the American Headache Society.
It works on proprietary technology design delivers patented waveform to C-fiber nerves, invoking descending analgesic mechanism in the brain stem. It is a non-invasive device with biodegradable electrodes which contains Theranica developed miniaturized chip and can be controlled by a smartphone.