Device Type: Transcutaneous Electrical Nerve Stimulation (TENS)
Manufacturer: STX Med: Cefaly Technology of Belgium
FDA Approval Date: March 11, 2014
What is Cefaly and how does it work
A migraine is a severe and painful headache that typically causes a throbbing pain in one side of the head. Migraine symptoms include nausea, vomiting and sensitivity to sound and light. It may occur at any time during the day but commonly occur in the morning. If untreated, a migraine attack can last from 4 to 72 hours. Approximately 18% of women and 6% of men in the United States suffer from migraines which reduces quality of life, causes lost productivity in the workplace, and affects loved ones.
Cefaly is a battery operated neurostimulation medical device worn across the forehead and over the ears. It works by applying an electric current to the skin, stimulating branches of the trigeminal nerve associated with migraine attacks. This is called transcutaneous electrical nerve stimulation (TENS). Stimulating the trigeminal nerve results in production of endorphins, chemicals that trigger a positive feeling. High levels of endorphins increase the migraine’s threshold (makes it harder for another attack to occur and results in fewer attacks. Second, by acting on the touch sensitivity fibers of the trigeminal nerve, it interrupts the pain signals to the brain.
What is Cefaly used for
Cefaly device is used for migraine prevention in individuals 18 years and older. It can help people who do not respond to current medications for preventing migraines. It is available only by prescription in the United States.
How effective is Cefaly
The safety and efficacy of Cefaly device was based on a study that included 67 participants who had more than two migraine attacks each month and were not on any medications to prevent migraines for three months. The participants who used Cefaly reported fewer days with migraines each month and used lower doses of acute medication to relieve their migraines than those in placebo group (not treated with Cefaly). In addition, there was data from the patient satisfaction study of 2,313 people who rented the device online. This study found that 53% of the participants were satisfied with this device and would purchase it for continued use.
What are interesting facts about Cefaly
- Cefaly is the first FDA-approved device for preventing migraines.
- It is the first transcutaneous electrical nerve stimulation (TENS) device for preventing pain.
- Cefaly reduces the frequency of migraine attacks, but does not prevent migraines completely.
- Cefaly is available in the United States only by prescriptions; however, it is available in other countries without prescriptions.
- You can order Cefaly online at www.cefaly.us. You must send a prescription before the device will be sent to you. Device delivery will start in April 2014.
- There is a 60-day money-back guarantee if you are not satisfied with the device.
- The company also offers a two-year warranty from the date of purchase.
How long is each Cefaly session?
Cefaly is approved for patients 18 years of age and above. The medical device should be worn no more than 20 minutes per day.
Cefaly Instructions for Use
Cefaly works via the electrode. Clean and degrease the forehead so the electrode will stick to the skin. Cefaly is placed just above the eyes and centered on the forehead using a self-adhesive electrode. Press the button to start the session.
Who should not use Cefaly?
- People with implanted metallic or electronic device in the head.
- People suffering from pain of unknown cause.
- People who have a cardiac pacemaker or implanted or wearable defibrillator to avoid interference with pacing, electric shock, or death.
What are the common side effects of Cefaly
There are no drug interactions associated with Cefaly since it is a medical device that does not contain any medications.
Cefaly can be combined with other medications used to prevent or treat migraines.
What is the cost of Cefaly?
Cefaly cost $295. The price of each Cefaly electrode kit containing 3 electrodes is $25. Each electrode is used up to 20 times.
Will insurance cover the cost of Cefaly?
Cefaly is not currently covered by medical insurance. Check with your insurance company.
Magis D; Sava S; D Elia TS; Baschi R; Schoenen J (Dec 1, 2013). "Safety and patients’ satisfaction of transcutaneous Supraorbital NeuroStimulation (tSNS) with the Cefaly® device in headache treatment: a survey of 2,313 headache sufferers in the general population.” J Headache Pain. 14(1): 95
FDA News Release. "FDA allows marketing of first medical device to prevent migraine headaches." March 11, 2014