FDA Clears Cefaly Device for Use During Migraine Attack

The latest approval green lights use of the device during a migraine attack with or without aura
The latest approval green lights use of the device during a migraine attack with or without aura

Cefaly Technology announced that the Food and Drug Administration (FDA) has cleared for use the Cefaly Acute medical device for the treatment of migraines, with or without aura, in patients ≥18 years of age.

Cefaly Acute is an external trigeminal nerve stimulator (e-TNS) approved for use under prescription. It is placed on the forehead, sending micro-pulses through an electrode to the upper branch of the trigeminal nerve.

The device, initially FDA-approved for the prevention of migraine attacks, is now cleared for use during a migraine attack with or without aura. “We are excited that our medical technology is unique and can treat a migraine as well as prevent a migraine,” said Dr. Pierre Rigaux, CEO of Cefaly Technology. 

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The approval was based on results from ACME (Acute Treatment of Migraine with External trigeminal nerve stimulation), a randomized, placebo control trial. Findings demonstrated that on average, Cefaly treatment reduced migraine pain by 65% and 32% of patients were pain free within 1 hour.

The Cefaly Acute device is expected be available in the next few months.

For more information visit Cefaly.us.