FDA regulators today announced landmark approval of a mobile headband-like device indicated for prevention of migraines and migraine pain. The device, called the Cefaly system, is the 1st of its kind and is indicated as an alternative to drug therapy.
The new Cefaly technology is a mobile, non-invasive nerve stimulation system that delivers electrical energy via a plastic band worn across the forehead. The device aims to stimulate the trigeminal nerve, which doctors believe is associated with migraines.
Patients aged 18 and up may use the technology for up to 20 minutes per day, with most respondents in a clinical trial reporting satisfaction and a desire to purchase one for themselves, according to the FDA memo.
Cefaly’s approval, granted through the FDA’s de novo fast-track for novel technologies, was based on results from a 67-patient study and a satisfaction survey with more than 2,300 respondents, the FDA said. A little more than half of the survey respondents reported satisfaction with the treatment, but the technology is not entirely without side effects.
Common adverse reactions, non of which were deemed "serious," included uneasiness with the tingling sensation sometimes associated with the device, sleepiness during treatment and headaches after treatment. For those with positive experiences, stimulation therapy helped cut down on the number of migraine days per month but did not completely eradicate migraines or reduce the intensity of migraines that did occur.
The technology was developed by STX-Med, a company based in Belgium and focused on electronic devices for human health and well-being, sometimes called "electroceuticals." In addition to migraine management, STX-Med is developing products for back and joint pain, posterior tension headaches, severe pain, paralysis, insomnia and wrinkles.
The Cefaly device is currently listed online for about $350.
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