Cefaly gets FDA nod for device to treat migraine attacks

The clearance follows the publication of clinical trial data on the Cefaly device.

The FDA has cleared Cefaly Technology’s device for the treatment of migraine attacks. Getting the FDA nod positions Cefaly to expand use of its external trigeminal nerve stimulation (e-TNS) device beyond preventative situations.

Cefaly secured FDA clearance to sell the device as a prophylactic treatment of episodic migraine in patients 18 years of age or older last year. Now, armed with data from an internet survey of more than 800 users of the device, Cefaly has got the green light to promote its Acute product to the much larger population of patients who need relief during migraine attacks.

Both approvals are underpinned by the same technology, although Cefaly has tweaked it for use in acute settings. The treatment is made up of an adhesive electrode and accompanying device that target the trigeminal nerve to change the trigger threshold for migraine. In prophylactic use, this is intended to cut the frequency of attacks. 


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Such preventative steps are only needed if a patient suffers an unusually large number of attacks. For most patients, relief during attacks is more important. This is the group Cefaly now hopes to help.

“We have developed a way for migraine patients to stop a migraine without medication and with next-to-no side effects,” Cefaly CEO Pierre Rigaux said in a statement.

That claim is backed up by some data. The FDA cited a retrospective, online study of the use of the device during acute attacks in its notice about the 510(k) clearance. But Cefaly has also put the device through prospective clinical trials, most notably a 106-patient double-blind, randomized, sham-controlled study. 

In that trial, participants in the treatment arm reported a 65% decrease in pain compared to their baseline readings. In the sham arm, a 32% reduction was seen. The difference was enough for the trial to achieve statistical significance against its primary endpoint. 

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