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Updated: June 10, 2019 Biotechnology

W. Hartford-linked migraine device wins FDA approval

Photo | Contributed Theranica’s Nerivio Migra device fits inside an armband.
Matt Pilon

An Israeli company that has developed a medical device that treats migraines is set to start selling its wares in the United States later this year, and a local physician is partly to thank.

The U.S. Food & Drug Administration recently approved Theranica’s “Nerivio Migra,” a non-invasive, smart-phone-enabled device that delivers electricity through an upper armband.

The FDA granted the device “De Novo” approval, which means it is considered a novel technology compared to existing products.

Dr. Brian Grosberg, director of the Hartford HealthCare Headache Center in West Hartford, was the principal investigator for the device’s clinical study.

Dr. Brian Grosberg, Director, Hartford HealthCare Headache Center

The randomized study took place at 13 sites across the United States and Israel between Dec. 2017 and Oct. 2018, and involved 252 patients who suffered from severe migraines.

Half were assigned to use Theranica’s device, while the other half were assigned a placebo device.

The study found statistically significant beneficial results for patients who used the device, including that nearly 67 percent felt pain relief two hours after receiving treatment, compared to less than 39 percent who used the placebo.

In addition, two hours after treatment, more than 37 percent of patients reported being free of migraine pain entirely.

The results caught the eye of other headache physicians around the country.

“It indicates that the device can provide patients with significant relief of pain and other migraine symptoms without the side effects presented by drugs,” said Messoud Ashina, president-elect of the International Headache Society.

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