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FDA gives approval to battery powered migraine prevention

Kathleen Blanchard's picture
TENS unit keeps migraines at bay for half of sufferers

Migraine sufferers now have a new way to thwart headaches that are not only debilitating but often require drug therapy with unwanted side effects. The drug free TENS unit could mean a drug free way to avoid migraines altogether for 36 million Americans who suffer from the disorder.

CEFALY Technology announced today that the FDA has approved the device that attaches to the forehead and looks like a headband. The TENS unit delivers an electrical current to branches of the trigeminal nerve. The trigeminal nerve is thought to play a role in migraine headaches and has three branches involved in sensory and motor function.

"The FDA approval of the Cefaly® medical device is a significant milestone for CEFALY Technology and for migraine patients across the United States,” said Doctor Pierre Rigaux, the chief executive officer of CEFALY Technology, the Belgian maker and a member of the team that invented Cefaly® in a press release sent to EmaxHealth. “It means for many episodic migraine sufferers preventative relief is just 20-minutes away.”

The migraine headache device is battery powered and requires a physician's prescription; is only for use for those over age-18 and should not be used if you are pregnant, planning pregnancy, or think you're pregnant.

In studies, patients with migraines were able to cut down on their medication use; 53 percent said they were satisfied with the TENS unit and there were no serious adverse effects reported. The migraine headache TENS unit decreased the number of migraine headaches in subjects tested, compared to placebo.

Researchers have noted that migraine prevention with medication is difficult because they either don't work or they have side effects.

The FDA approval comes from a review of a 67 patient study combined with a patient satisfaction survey from 2,313 Cefaly® users in France and Belgium.

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If you suffer from migraines, speak with your doctor to see if the migraine headache treatment might help you. You can try the device for a smaller fee than the purchase if you're not sure. According to the manufacturer most people get used to the "strange and unusual" sensation that occurs from the electrical current, but some experience pain. The treatment is also not covered by most insurances, but you can speak with your carrier to see if reimbursement is available. The drug-free migraine prevention device is available in the US, Canada and Europe.


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how do I get the device here in Australia,i know its only available in certain countries,but would love to be a trial subject here in Australia. I suffer from cluster headaches and have for about 20 yrs, hope is our journey...
Trevor, best to you. I am so sorry you are dealing with this. Do speak with your healthcare provider for options as well as the manufacturer for details.
hi there , I am also struggling with very bad migraines do you have or can you recommend something good to use please?
I have suffered with benign recurring headaches all of my life. My father had headaches also. I have been to doctor after doctor and believe it or not most doctors do not believe in headaches like I have.. But I found a Pain Clinic that helps me and treats mine. But headaches are REAL and don't let any Dr. Discourage you. I stil have them but keep up the work and don't give up !!!