TUESDAY March 11, 2014, 2014 — The U.S. Food and Drug Administration on Tuesday approved the first device aimed at preventing migraines.
The device, called Cefaly, is a headband-like device that runs on a battery and sits across the forehead and over the ears, the FDA said in a statement.
“The user positions the device in the center of the forehead, just above the eyes, using a self-adhesive electrode,” the agency explained. “The device applies an electric current to the skin and underlying body tissues to stimulate branches of the trigeminal nerve, which has been associated with migraine headaches.”
Cefaly is made by Belgium-based Cefaly Technology and is available by prescription only. The device is only indicated for use by adults and should only be used for 20 minutes per day, the FDA said. The agency also noted that “the user may feel a tingling or massaging sensation where the electrode is applied.”
CEFALY DRUG-FREE MIGRAINE PAIN RELIEF
Millions of Cefaly treatments studied have proven that it is an effective, drug free, migraine pain reliever – Join the tens of thousands of people around the world who have tried Cefaly and are free of migraine pain and pain relieving medication.
Cefaly is a drug-free method for treating migraine pain and preventing migraine headaches from ever coming on. Cefaly treats migraine pain with neurostimulation. A stimulus that limits pain signals from the nerve centre by working on the trigeminal nerve where migraine headaches start. The patented Cefaly treatment changes the trigger threshold of migraine headaches. As the pain threshold becomes harder to reach, migraine headaches are less frequent, less painful, and simply disappear.
Cefaly offers patients suffering from migraine pain and headaches an efficient electrotherapeutical system delivered via an extremely comfortable, ergonomic and simple-to-use medical device.
WHAT IS CEFALY
Cefaly is a CE and ISO certified medical device designed to treat and prevent migraine headaches. Cefaly can considerably reduce or replace the consumption of side effect producing medications. Cefaly is the first cranial analgesic electrotherapeutic device to acquire ISO medical certification proven effective on migraine pain with no side effects.
Cefaly’s patented design uses TENS technology which has been researched in medical circles for over 40 years. TENS technology is known for its safety and dramatic absence of side effects, making Cefaly unique to all other headache and migraine pain treatments.
Cefaly is designed and developed in accordance with the strictest quality standards eliminating all possible short-term and long-term dangers.
Cefaly is an innovative, lightweight and extremely cost effective pain relieving solution. Its self adhesive electrode is placed directly on to the forehead. Worn conveniently like a pair of eyeglasses, Cefaly connects to the electrode and begins its subtle treatment.