FDA Approves First Medical Device For Preventative Treatment of Migraine Headaches

In March of 2014, the FDA announced that they would allow marketing of the first transcutaneous electrical nerve stimulation (TENS) device for the preventative treatment of migraine headaches.1

Cefaly is a small, portable, battery-powered device similar to a headband and is worn across the forehead, resting on top of the patient’s ears.1 The device is positioned in the center of the patient’s forehead using a self-adhesive electrode. The bipolar electrode bilaterally covers the origins of the supraorbital nerves (branches of the 1st trigeminal division) while a constant current generator produces biphasic rectangular impulses.2 These impulses cause a tingling or massaging sensation; the patient has the ability to control the intensity should it be too much when treatment is first started.Cefaly should be used once daily for 20 minutes, during which time the patient can relax or continue with daily activities.

While this device is new, the use of TENS for the treatment of pain is well established.3 TENS has been shown to reduce pain both peripherally (involving opioid and α-2 noradrenergic receptors) and centrally (activating sites in the spinal cord and brainstem that utilize opioid, serotonin, and muscarinic receptors).

Data for Cefaly were reviewed by the FDA through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk medical devices that are not substantially equivalent to an already approved device.1

Cefaly was approved based on data from two separate studies. The first was a randomized double-blind, placebo-controlled trial that enrolled 67 patients across 5 Belgian headache clinics over a 3-month period.4 The mean number of migraine days decreased significantly in patients using Cefaly (6.94 vs 4.88; P = 0.023), but not in patients using the placebo device (6.54 vs 6.22; P = 0.608). Monthly migraine attacks (P = 0.044), monthly headache days (P = 0.041), and monthly acute antimigraine drug intake (P = 0.007) were also significantly reduced in patients using Cefaly. The FDA also reviewed data from a large safety and patient satisfaction survey of 2,313 patients who rented the Cefaly device for a 40-day period.2 Adverse events (AEs) and willingness to continue were monitored via phone interviews after the trial period. After an average testing period of 58.2 days, 54.4% of subjects were satisfied with treatment and willing to purchase the device, while 46.6% were not satisfied and returned it. However, a compliance check showed that those who were not satisfied only used the device for 48.6% of the recommended time. A total of 4.3% subjects reported one or more AEs, but none were serious. The most frequent AEs were local pain/intolerance to paresthesia (2.03%), arousal changes (mostly sleepiness/fatigue, sometimes insomnia, 0.82%), and headache after the stimulation (0.52%).

The cost of Cefaly is $295 plus an additional $25 for a set of 3 electrodes; a prescription is required. This device is a unique prophylactic treatment for episodic migraine in patients 18 years of age or older, and may help patients who have difficulty tolerating other migraine medications.

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