The U.S. Food and Drugs Administration approved the marketing of the first medical migraine prevention device, "Cefaly," developed by STX-Med in Herstal from Belgium.
According to the administration, Cefaly is the first transcutaneous electrical nerve stimulation (TENS) device specifically authorized for use prior to the onset of pain due to migraine headaches.
"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 in a press statement. "This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks."
Approval for marketing of the device was given after the FDA reviewed the device through the de novo premarket review method. The review pathway is generally used to analyze low to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.
Data from a clinical study conducted in Belgium involving 67 individuals was used to evaluate the safety and effectiveness of the device. All the individuals in the study experienced more than two migraine headache attacks a month and had not taken any medications to prevent migraines for three months prior to using Cefaly.
Researchers found that the individuals 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.
Another study was conducted on 2,313 Cefaly users in France and Belgium top evaluate patient satisfaction among the device users. The FDA found that more than 53 percent of patients were satisfied with Cefaly treatment. They were also willing to purchase the device for daily usage.
Some of the complaints received from Cefaly users included awkward feeling while using the device, sleepiness during the treatment session, and headache after the treatment session.
The device is a small, portable, battery-powered, prescription that resembles a plastic headband worn across the forehead and atop the ears. It needs to be placed at the center of the forehead, just above the eyes. Cefaly then applied an electric current to the skin to stimulate branches of the trigeminal nerve.
The FDA warned that users may feel a tingling or massaging sensation where the electrode is applied. Cefaly is recommended for patients 18 years of age and older and should only be used once each day for 20 minutes.
Statistics show that more than 37 million Americans suffer from migraines. Some migraine studies estimate that 13 percent of adults in the U.S. population have migraines, and 2-3 million migraine suffers are chronic. Almost 5 million in the U.S. experience at least one migraine attack per month, while more than 11 million people blame migraines for causing moderate to severe disability.
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