US widely sells migraine prevention device

On March 11, the US Food and Drug Administration (FDA) approved the widespread sale of a transcutaneous electrical nerve stimulation (TENS) device for the prevention of migraines, manufactured by the Belgian company STX-Med.

(Source: STX-Med)

TENS was the first device approved in the US for pre-emptive migraine prevention and is marketed under the name “Cefaly”. It is a small, handheld device shaped like a headband that the user places on the center of the forehead using a self-adhesive electrode.

The device sends an electrical current through the skin and muscle tissue to stimulate branches of the trigeminal nerve associated with migraines. Users may experience a tingling or massaging sensation where the electrodes are attached.

According to the FDA, "Cefaly" is indicated for patients 18 years of age and older and should only be used once a day for 20 minutes. The marketing authorization for this device was based on the analysis of data obtained after clinical trials on 67 migraine sufferers in Belgium.

Research results show that people using the device will significantly reduce the number of days with migraines in a month and use less medication to treat this disease than those using a placebo./.

According to VNA