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FDA Approves First Device to Prevent Migraine
Medscape Medical News
March 11, 2014

The US Food and Drug Administration (FDA) today allowed marketing of the first device for the preventive treatment of migraine headaches (Cefaly, STX-Med).

It is also the first transcutaneous electrical nerve stimulation (TENS) device specifically authorized for use before the onset of pain, the FDA noted in a statement released today.

"Cefaly provides an alternative to medication for migraine prevention," Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, said in the statement. "This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks."

The device, which resembles a plastic headband worn across the forehead and over the ears, stimulates the trigeminal nerve using a self-adhesive electrode in the center of the forehead. "The user may feel a tingling or massaging sensation where the electrode is applied," the FDA notes. "Cefaly is indicated for patients 18 years of age and older and should only be used once per day for 20 minutes."

The FDA reviewed the data for Cefaly through the de novo premarket review pathway, a regulatory pathway for generally low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.

Two Studies
The approval was based on data from a clinical study conducted in Belgium involving 67 individuals who experienced more than 2 migraine headache attacks a month and who had not taken any medication to prevent migraines for 3 months before using the device, as well as a patient satisfaction study of 2313 device users in France and Belgium.

The 67-person study, published in Neurology, showed that those who used the device experienced significantly fewer days with migraines per month and took less migraine attack medication than those who used a placebo device. The device did not completely prevent migraines and did not reduce the intensity of migraines that did occur, the FDA notes.

"The patient satisfaction study showed that a little more than 53% of patients were satisfied with Cefaly treatment and willing to buy the device for continued use," the statement adds. "The most commonly reported complaints were dislike of the feeling and not wanting to continue using the device, sleepiness during the treatment session, and headache after the treatment session."

No serious adverse events occurred during either study, the agency notes.

The device is already available in Europe, as well as several South American and Middle Eastern countries and Canada.


Migraine 'Headband' Wins FDA Approval
Medpage Today/Neurology
March 11, 2014

A headband delivering electrical nerve stimulation can prevent onset of migraine headaches and can be marketed for that purpose in the U.S., the FDA said Tuesday.

Called Cefaly, the Belgian-made device is the first to win FDA approval for migraine prevention and is also the first transcutaneous electrical nerve stimulation (TENS) system OK'd for any type of pain prevention, as opposed to acute treatment, the agency said.

The device is battery-powered and worn around the head, with the actual TENS stimulator centered on the forehead just above the eyes. It delivers a small, steady current to trigeminal nerve branches. Patients will be instructed to use the device once daily for a maximum of 20 minutes. It is approved for adults only.

Approval was based primarily on the PREMICE trial[SUB]PDF attached[/SUB], in which 67 adult patients were randomized to wear either the Cefaly device or a nonfunctional sham. When turned on, the device typically causes a tingling sensation, but the trial investigators sought to maintain blinding by not asking participants what it felt like and by trying to keep them from talking with each other.

Patients assigned to the real device showed a decline from baseline of about two headache days per month, compared with no change in the control group. A responder analysis showed that 38% of patients receiving stimulation had at least a 50% reduction in monthly headache days, compared with 12% of the control group.

The Cefaly device was previously approved in Europe and Canada. The device's manufacturer, STX-Med of Herstal, Belgium, submitted results of a patient satisfaction survey conducted among more than 2,000 users in Europe, indicating that most regular users believed they had experienced "very significant improvement" and only 4% reported adverse effects.

Across the entire respondent group, including those who only used the device infrequently or not at all, 54% reported substantial improvement.

Complaints about the device included dislike of the tingling sensation, sleepiness during the treatment sessions, and headache following the sessions, the FDA said. None of the reported adverse effects were considered serious.

Numerous TENS devices are already marketed for pain treatment.


  • Nerve Stimulation Cuts Down on Migraines.pdf
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