Cefaly Device Approved by the FDA for Migraine Treatment
On March 11 (2014), the FDA approved the Cefaly external trigeminal nerve stimulator (eTNS) preventing and treating Migraine attacks. Cefaly is manufactured by STX-Med in Herstal, Liege, Belgium.
Before I continue, it's vitally important to understand that although the information released by the FDA calls this a transcutaneous electrical nerve stimulation (TENS) unit, it is actually an eTNS device. This is important because TENS units cannot be safely usen the head or face. Do not attempt to use any TENS unit above the neck without the assistance and instruction of your doctor.
Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, commented:
"Cefaly provides an alternative to medication for migraine prevention... This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks."1
Cefaly is a small, portable, battery-powered (AAA batteries) device that many people have said resembles Wonder Woman's headband worn across the forehead and atop the ears. The user positions the device in the center of the forehead, just above the eyes, using a self-adhesive electrode. The device applies an electric current to the skin and underlying body tissues to stimulate branches of the trigeminal nerve, which becomes inflamed during a Migraine attack. The user may feel a tingling or massaging sensation where the electrode is applied. Cefaly is approved for patients 18 years of age and older.
The FDA evaluated the safety and effectiveness of the device based on data from a clinical study conducted in Belgium involving 67 individuals who experienced more than two Migraines a month and who had not taken any Migraine preventive medications for three months prior to using Cefaly, as well as a patient satisfaction study of 2,313 Cefaly users in France and Belgium.
Dr. Michele Vandenheede, who conducted the study in Belgium said that the Cefaly produced a 50% reduction in the number of Migraine attacks and reduced dramatically the use of analgesics for Migraines. The 67-person study showed that those who used Cefaly experienced significantly fewer Migraine attacks per month and used less acute medication than those who used a placebo device. The device did not completely prevent Migraines.
The patient satisfaction study showed that a little more than 53 percent of patients were satisfied with Cefaly treatment and willing to buy the device for continued use. 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.
Here's a video that shows how the Cefaly is used and works as well as comments from doctors:
**Summary and Comments:**Although the Cefaly is available without a prescription in other countries, the FDA has decided decreed that it be available in the United States only _WITH _ a prescription. Personally, I think it's pathetic that it took years longer for approval in the U.S. than it did in other countries and that the FDA is treating us like children by requiring a prescription. (stepping down from my soapbox now)
Despite the requiring a prescription, the FDA approval is good news. People desperate to try anything that might help have been ordering the Cefaly from Canada. Now we can order it from Cefaly.us. There are instructions on their order page for emailing in a prescription. In the U.S., the Cefaly costs $295, and comes with one electrode, which is good for seven to 10 sessions. Replacement electrodes are $25 for three.
I've spoken with Dr. David Watson, my Migraine specialist, and we've decided it's worth a try. He's going to email a prescription for me. After I've tried it for a month or so, I'll be writing again to report my results.
1 FDA News Release. "FDA allows marketing of first medical device to prevent migraine headaches." March 11, 2014.
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