NEW YORK - Cefaly Technology on Monday relanuched its "wearable" for the treatment of migraines after undergoing a massive makeover, the company announced.
Cefaly I, which gained popularity for its unique headband-like shape, is now three-quarters its size, fits in the palm of a person's hand, is rechargeable, uses magnets to stay in place and allows patients more control over the intensity of their daily session. The new Cefaly II, is available exclusively in the United States; it will become available next in Europe in September.
"This compact device is so easy to tuck in a pocket or purse and I am hopeful it will further increase compliance and bring an even larger reduction in migraine attacks to patients," stated Pierre Rigaux, CEO Cefaly Technology. "Cefaly I has a tremendous success record. In clinical trials 81% of compliant patients showed a significant reduction in migraine attacks and up to a 75% reduction in consumption of migraine medications. Now that the device is so small, it's a big deal because patients can have their Cefaly II with them wherever they go, which means they'll be able to use it more readily, at their most convenient time."
Cefaly is an electronic, battery-powered, device that is placed on the forehead for 20-minutes once a day, using a self-adhesive electrode and a magnetic connection. The device sends tiny electrical impulses through the skin to desensitize the upper branches of the trigeminal nerve and reduce the frequency of migraine attacks. The new device allows patients to control their session by ramping up the intensity to their desired comfort level. Also, the introduction of a magnetic connection means the device will more quickly fall into place – and more securely maintain its connection – rather than be affixed to a fastener where a small movement could occasionally interrupt the session.
Also new is a built-in rechargeable Lithium-ion Polymer 3.7 V battery that replaces the two AAA batteries, which contributed to the device's shape and bulk. The new battery allows for the Cefaly II to be charged either by a USB cable on a home or work computer, or through a wall charger.
The new pocket-sized Cefaly II device includes a USB cable, wall charger, a storage case and one electrode. The device costs $349 and comes with a 60-day money back guarantee.
A pack of three electrodes costs $25; each electrode may be re-used up to 20 times.
Cefaly II is available by prescription-only and indicated for patients 18 years of age and older. Women who are pregnant or could become pregnant should check with their doctor before using Cefaly. In clinical trials, only 4.3% of people reported side effects - all of which were minor and fully reversible.