FDA allows marketing of first medical device to prevent migraine headaches

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Today, the U.S. Food and Drug Administration allowed marketing of the first device as a preventative treatment for migraine headaches. This is also the first transcutaneous electrical nerve stimulation (TENS) device specifically authorized for use prior to the onset of pain.


“Cefaly provides an alternative to medication for migraine prevention,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks.”

Migraine headaches are characterized by intense pulsing or throbbing pain in one area of the head, accompanied by nausea or vomiting and sensitivity to light and sound. A migraine can last from four to 72 hours when left untreated. According to the National Institutes of Health, these debilitating headaches affect approximately 10 percent of people worldwide and are three times more common in women than men.

Cefaly is a small, portable, battery-powered, prescription device that resembles a plastic headband worn across the forehead and atop the ears. The user positions the device in the center of the forehead, just above the eyes, using a self-adhesive electrode. 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. The user may feel a tingling or massaging sensation where the electrode is applied. Cefaly is indicated for patients 18 years of age and older and should only be used once per day for 20 minutes.

The FDA reviewed the data for Cefaly through the de novo premarket review pathway, a regulatory pathway for generally low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.

The agency evaluated the safety and effectiveness of the device based on data from a clinical study conducted in Belgium involving 67 individuals who experienced more than two migraine headache attacks a month and who had not taken any medications to prevent migraines for three months prior to using Cefaly, as well as a patient satisfaction study of 2,313 Cefaly users in France and Belgium.

The 67-person study showed that those who used Cefaly experienced significantly fewer days with migraines per month and used less migraine attack medication than those who used a placebo device. The device did not completely prevent migraines and did not reduce the intensity of migraines that did occur.

The patient satisfaction study showed that a little more than 53 percent of patients were satisfied with Cefaly treatment and willing to buy the device for continued use. The most commonly reported complaints were dislike of the feeling and not wanting to continue using the device, sleepiness during the treatment session, and headache after the treatment session.

No serious adverse events occurred during either study.

Cefaly is manufactured by STX-Med in Herstal, Liege, Belgium.

Source: USFDA Consumer Alerts

Why Cefaly?

  • Pain Prevention: A prevention program designed to increases the production of endorphins and raises the trigger threshold of the pain.
  • No Side effects: Stop depending on pain killers and side effect producing medication. Cefaly can replace or reduce the consumption of painkilling medication, with no side-effects.
  • Effective pain relief: A Attack program blocks pain and provides relief during attacks.
  • Reduce Stress: An anti-stress program produces general relaxation and a strong sense of well-being.

Is it safe?

Cefaly is harmless and very safe to use. Its safety has been demonstrated in test and clinical studies Cefaly is a patented medical device supported by numerous clinical studies and safety tests.
Clinically studied over 5 years in university hospital pain clinics and in specialist laboratories. Designed and developed in line with a strict risk analysis compliant with international standard ISO 14971 applicable to medical equipment.
Cefaly complies with directive 93/42/EEC pertaining to medical devices and with all associated international IEC standards.

Who Can Use Cefaly?

Migraine Headaches affect people of all ages. Cefaly is designed to only to act on physiological mechanisms therefore it is not age dependent, although as added precaution we recommend it only to children over 8 years old.
Cefaly is ideal for pregnant or nursing mothers who have no choice but to stay away from dangerous pain killing medication.
If used as directed children over 8 years old may use Cefaly if supervised by an adult.

Any side effects?

Cefaly was designed with safety in mind, all the substances and materials used are bio-compatible and have been subjected to skin testing.
No clinical studies carried out with Cefaly have revealed any evidence of side effects or problems.
Millions of pain treatments, using Cefaly have been monitored and no problems or side effects were reported.

Precautions & Recommendations

  • Do not use Cefaly while driving
  • Redness of the skin in the area around the electrode may persist for a few minutes after the session has ended
  • If you have had recent brain or facial trauma
  • If you have a skin abrasion on the forehead in the area of application of the electrode
  • If you have Meniere’s disease

Source: http://www.cefaly.ca


One thought on “FDA allows marketing of first medical device to prevent migraine headaches

    balasubramanian said:
    May 23, 2014 at 9:46 am

    there are humty number og these patients searching for a cure or atleast some relief..if this helps it will be a great service…

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