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.
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.