FDA Approves First Device to Prevent Migraine

http://www.medscape.com/viewarticle/821810?src=wnl_edit_newsal&uac=142709SZ
Susan Jeffrey
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.

I own a TENS unit. I wonder if I can use that to achieve this effect....

Found a picture - makes you look like Wonder Woman. http://www.electronichealing.co.uk/cefaly_for_migraine.htm

THANK YOU for this info.  I got all excited until I read that it was not yet available in the US until I did a further search and found that earlier today the FDA has approved the Marketing of it here.  I'm going for the Nerve Block tomorrow and will show this info to my Doctor and ask his opinion of it and see if he can find out if it is available through prescription here in the US or just when it will be. 

In further searching, I found that it is available in Canada at Costco for $249.00 (Canadian) and the electrodes are 2 x 3-pack (6 in total) for $36.99 (Canadian) and it says "Shipping and Handling included".  Hmmmmmmmm  Do you have to be a member of Costco like you do at SAM'S CLUB?

My husband has a TENS unit and we have often said that we wished it would work on my daily MONSTERS.

Once again, thank you so much for this ray of hope in this sea of darkness I call "Living with the MIGRAINE MONSTERS"!

Lori

I have one. Bought it a couple of years ago. It had no effect. No you don't have to be a member at Costco to buy from their site. We're all different so perhaps it will work for someone else.

i hate to be a wet blanket here, but look at the study.  67 people is insignificant, and only half of those found the thing useful. the other study of 2300 individuals is still a mighty small number.  

we are all desperate for something to work, i totally realize.  personally, i've been waiting for 45 years.  but the triptans are my saving grace, and they do keep my functional MOST of the time.  i feel really bad for people for whom nothing (so far) has helped.  

those of us who've been around this painful block for so many years are likely to be most skeptical, so don't listen to me!  i did try the TENS unit and it did nothing.  there are so many different causes for our head pain, and i would be interested in hearing what your doctor doing the nerve blocks thinks of this new device.  please report as possible.  thanks, dianne

http://www.thejournalofheadacheandpain.com/content/14/1/95

This is talking about a study with over 2,000 participants. I don't personally have much hope, seeing as only half of them were satisified enough to spend the money. Maybe it's worth a try

(My first post.) I had a really bad migraine recently at my sister's house. Her husband had just read about the "tiara," as he calls it, and, without telling me, ordered it for me from the UK. It arrived at their house the day I left, so she is forwarding it on to me. I will post when I know whether it helps.

Thanks and I truly hope it gives you relief!!  Might give hope to the rest of us.

Lori

charmed quark wrote:I own a TENS unit. I wonder if I can use that to achieve this effect....

I have read that it is dangerous to use a TENS unit intended for one purpose for another purpose. I would ask my dr first.

Seaine wrote:http://www.thejournalofheadacheandpain.com/content/14/1/95

This is talking about a study with over 2,000 participants.  I don't personally have much hope, seeing as only half of them were satisified enough to spend the money.  Maybe it's worth a try

The study says, though, that those who were dissatisfied used it less than half the time they were supposed to. Frankly, I don't see how they got this study approved and published, but there you go.