FDA Allows Marketing of a First-of-its Kind Device To Stop Migraines
Published By : 12 Mar 2014 | Published By : QYRESEARCH
The Food and Drug Administration of America has today allowed marketing of the first medical device that can act as a preventive measure against migraine headaches.
Cefaly, as it is named, is a plastic headband like device that can be directly worn right on the centre of forehead with its self adhesive electrode. After connecting to the forehead, the electrode in this device starts emitting neurostimulation (a kind of electric current) to the skin and the tissues under it. This stimulus starts working on branches of the trigeminal nerve by limiting pain signals from it.
Cefaly is a prescription device and meant for patients of 18 years and older ages. It is small, portable, battery powered and can be worn like a pair of glasses.
Cefaly is meant as an alternative to the medicines commonly prescribed for migraine and targets patients who cannot tolerate their current medication for treating or preventing the condition that is characterized by throbbing head pain, vomiting, nausea and sensitivity to light and sound. Typical migraine attacks last for many hours and can extend up to 72 hours if not treated.
It is been estimated that no less than 10% people in the world suffer from minute to acute variants of the condition and it is three times more common in women than in men.
FDA based its decision to allow marketing of Cefaly by evaluating its safety and effectiveness observed in a clinical study conducted in Belgium and involving 67 individuals who were prone to more than two migraine attacks in a month. The individuals under the clinical study did not take any preventive medication for migraine for three months prior to the use of Cefaly. A patient satisfaction study of 2,313 Cefaly users from France and Belgium was also taken into consideration.
The clinical study of 67 people showed that using Cefaly affected in significantly less days of migraine per month with complete avoidance or somewhat reduced medication. The device, however, did not reduce the intensity of migraine that occurred.
The other study that surveyed patient satisfaction showed that more than 53% of the observed participants were satisfied with Cefaly and were willing to buy it for continued use. No serious adverse effects were seen during either of the studies.
Cefaly is manufactured in Herstal, Liege, Belgium by STX-Med