FDA gives approval to battery powered migraine prevention
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.