Health & Medicine
FDA Approves Medical Device to Prevent Migraine Headaches [VIDEO]
Staff Reporter
First Posted: Mar 12, 2014 05:11 AM EDT
The U.S. Food and Drug Administration approved the marketing of a Belgium-made medical device to prevent migraine headaches, earlier this week.
The first medical device 'Cefaly' manufactured by STX-Med, Belgium, is similar to a plastic headband that is meant to be worn across the forehead and on the ears. This device is the first transcutaneous electrical nerve stimulation device (TENS) that is mainly authorized for use before migraine attacks.
"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 news release. "This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks."
The prescribed product is defined as a small, portable, battery-powered device that is recommended for patients above 18 years of age and older. The device is meant to be positioned at the center of the forehead with the help of a self adhesive electrode and should be used for just 20 minutes a day.
On using the device, a small dose of electric current is applied to the skin and the underlying body tissue to stimulate the branches of the trigeminal nerve that is linked to migraine attacks. The agency cautions that the user may experience a slight tingling or massaging sensation.
The federal agency examined the product through the premarket review pathway. To test the safety and effectiveness of the device, they examined the data of a clinical study that was conducted on 67 people from Belgium. These individuals experienced more than two migraine headache attacks in a month and had not been treated three months before the use of Cefaly. They also examined the data of a patient satisfaction study that was done on 2,313 Cefaly users in France and Belgium.
The first study on 67 individuals revealed that those who used Cefaly experienced fewer days with migraines per months and also used less medication to prevent the attacks. The device not only helped prevent migraine, but also lowered the intensity of migraine whenever it occurred.
The other patient satisfaction study showed that the 53 percent of the users continued to use the device as they were satisfied with the treatment. The participants reported feeling a bit drowsy during the treatment session and experienced headaches after the treatment session. Other than that, there were no adverse side effects.
According to the statistics of the National Institutes of Health, migraine headache affects nearly 10 percent of the population worldwide and is three times more prevalent in females than males. Migraine headache is defined as an intense pulsating pain in a certain area of the head and generally causing nausea, vomiting or extreme sensitivity to light and sound. A migraine attack is known to last between four and 72 hours, if left untreated.
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First Posted: Mar 12, 2014 05:11 AM EDT
The U.S. Food and Drug Administration approved the marketing of a Belgium-made medical device to prevent migraine headaches, earlier this week.
The first medical device 'Cefaly' manufactured by STX-Med, Belgium, is similar to a plastic headband that is meant to be worn across the forehead and on the ears. This device is the first transcutaneous electrical nerve stimulation device (TENS) that is mainly authorized for use before migraine attacks.
"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 news release. "This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks."
The prescribed product is defined as a small, portable, battery-powered device that is recommended for patients above 18 years of age and older. The device is meant to be positioned at the center of the forehead with the help of a self adhesive electrode and should be used for just 20 minutes a day.
On using the device, a small dose of electric current is applied to the skin and the underlying body tissue to stimulate the branches of the trigeminal nerve that is linked to migraine attacks. The agency cautions that the user may experience a slight tingling or massaging sensation.
The federal agency examined the product through the premarket review pathway. To test the safety and effectiveness of the device, they examined the data of a clinical study that was conducted on 67 people from Belgium. These individuals experienced more than two migraine headache attacks in a month and had not been treated three months before the use of Cefaly. They also examined the data of a patient satisfaction study that was done on 2,313 Cefaly users in France and Belgium.
The first study on 67 individuals revealed that those who used Cefaly experienced fewer days with migraines per months and also used less medication to prevent the attacks. The device not only helped prevent migraine, but also lowered the intensity of migraine whenever it occurred.
The other patient satisfaction study showed that the 53 percent of the users continued to use the device as they were satisfied with the treatment. The participants reported feeling a bit drowsy during the treatment session and experienced headaches after the treatment session. Other than that, there were no adverse side effects.
According to the statistics of the National Institutes of Health, migraine headache affects nearly 10 percent of the population worldwide and is three times more prevalent in females than males. Migraine headache is defined as an intense pulsating pain in a certain area of the head and generally causing nausea, vomiting or extreme sensitivity to light and sound. A migraine attack is known to last between four and 72 hours, if left untreated.
See Now: NASA's Juno Spacecraft's Rendezvous With Jupiter's Mammoth Cyclone