FDA Approves First Device to Prevent Migraine (Cefaly)

Medscape ^ | March 11, 2014 | Susan Jeffrey

[Stoat]

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.

[Stoat]

Also:

Migraine treatment Cefaly - Cefaly

Neurostimulation Effective in Migraine Prevention

 

 

 

Cefaly® Anti-migraine Device

 

*************************************

The 67-person study, published in Neurology,

**********

 a patient satisfaction study of 2313 device users in France and Belgium....

*********

"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,"

****************************************************************

I don't get migraines, but if I did these numbers would give me pause before I would rush out to buy one at $250. or  more.

[DanZ]

As you said - You do not get migraines.

This may prove a good option for those of us who do get migraines. In my case Ibuprofen, if taken at the onset of a migraine works well.

[Dr. Bogus Pachysandra]

Well, I used to get them. Codeine was the only thing that helped. I seem to have outgrown them, as did my Father.

[Crazieman]

Same. Ibuprofen before the onset.

Unfortunately I had a wicked attack a few days ago because it came upon me while I was asleep. Woke up to it. Not fun.

[wally_bert]

Nothing seems to do anything for me except for quiet and dark. Been that way all my life.

[bgill]

Oh, I thought they were removing the usurper from office. That cure many a migraine immediately.

[Lx]

I found that Ibuprofen before the attack gets going in earnest is the best bet but it has stopped a major one going full bore, too. Luckily, I haven’t had any in years, they were crippling when they happened though.

Ergotamine tartrate which you need to get from a Doctor works as well if you use it at the first sign of one coming on. A friend’s mom got them so bad that that didn’t help most of the time. I wonder how this device would work on her?

[Dr. Bogus Pachysandra]

I did the Ergotamine deal. Never really seemed to help. Thank goodness I’ve outgrown them. All kinds of problems when, on vacation, my Dad and I both were incapacitated. My 16 year old Sister had to drive. That was as worrying as the headaches!

[Lx]

The ergotamine didn’t work that well on me either. The earlier you detected the migraine coming on and then the application of ergotamine seemed best.
I didn’t know you could outgrow them but I think I have too. I’ve had some where the only thing you could do was to go into a darkened and silent room to ride it out. Driving with one is no fun at all.

[Excellence]

bfl

[Organic Panic]

I DO get migraines and if this has those chances $250 is worth it to me. It puts me down a good 2 days. The worst is when it kicks in and you know you’re going to get it. It is to the point of near blindness for me. Then the fun of headache and vomiting. It’s ALMOST as bad as being stuck someplace that has an Obama speech on the TV. At least migraines go away...

[SkiKnee]

I get "Cluster Headache" migraines, which can be some of the nastiest little buggers you'd ever want to experience.

An Imatrex nasal spray came on the market a couple of years ago which seemed to help for a short while. But the only real remedy for me is to breath pure oxygen. Stops the attack in its tracks. Plus 350mg daily Verapamil as a long-term prevention has kept me free of them for more than a year now. For the most part, anyway. I still experience an occasional episode but they are short lived and not nearly as severe.

[GGpaX4DumpedTea]

Use Iodine...

Drs. Abraham, Flechas and Brownstein tested more than 4,000 patients taking iodine in daily doses ranging from 12.5 to 50 mg, and in those with diabetes, up to 100 mg a day. These investigators found that “iodine does indeed reverse fibrocystic disease; their diabetic patients require less insulin; hypothyroid patients, less thyroid medication; symptoms of fibromyalgia resolve, and patients with migraine headaches stop having them.” We can expect even better results when iodine is combined with magnesium chloride.

“patients with migraine headaches stop having them”

Iodine is a simple solution in this case...and most of us are deficient. There are several options out there for Iodine supplementation, and I think Lugol’s Iodine is a good choice...inexpensive and effective.

[Dr. Bogus Pachysandra]

“the only thing you could do was to go into a darkened and silent room to ride it out. Driving with one is no fun at all.”

My Dad and I both got hit on the day we were suoposed to drive home from Killington to Cleveland. Terrible trip!