FDA-Approved Cefaly® Device to Stop Migraines Now Available In Bahrain
Renowned for helping prevent migraine attacks, a new FDA clearance paves way for Cefaly DUAL device that can now stop a migraine in progress and prevent a future episode too.
Gulf Markets International W.L.L., Healthcare Business announces the release of a new U.S. Food and Drug Administration (FDA)-approved migraine treatment devices. Cefaly® DUAL , already the first FDA-approved external Trigeminal Nerve Stimulation (e-TNS) device for the prevention of migraine attacks, is now the only migraine device available for use during a migraine attack with or without aura. The Cefaly® DUAL can help rescue a migraine already in progress and also help patients to prevent migraine without medication. Cefaly is a non-drug, non-invasive migraine treatment that offers the best safety/efficacy ratio compared to current anti-migraine medication.
“We are excited that we can now offer to migraine patients in Bahrain a new drug-free option in their migraine care”, said Mr. Dimitri Mestre, the Export Manager of CEFALY Technology. “We have developed a way for migraine patients to stop a migraine and prevent a migraine without medication and with next-to-no side effects."
The new FDA-approval follows several clinical trials that demonstrated that one hour of e-TNS with the Cefaly® DUAL can relieve or stop the migraine headache. Results from the acute treatment of migraine with external trigeminal nerve stimulation double-blind randomized placebo control trial were presented at a recent meeting of the International Headache Society. The findings showed that on average, the Cefaly® DUAL treatment reduced migraine pain by 65%. In addition, 32% of patients were pain free within an hour. In other clinical trials for migraine prevention with Cefaly, 81% of compliant patients showed a significant reduction in migraine attacks and up to a 75% reduction in consumption of migraine medications.
Proprietary Cefaly® technology has been adapted to efficiently and safely address the different phases of migraines. There are now two treatment options combined in one unit : a prophylaxis treatment and a rescue treatment in Cefaly® DUAL; a device that combines both prevent and acute technologies. The device is administered in a simple way: a device is placed on the forehead via a magnetic connection to a self-adhesive electrode, which then sends precise micro-impulses through the skin to the upper branches of the trigeminal nerve to either relieve headache pain during a migraine attack or to prevent a future migraine attack.
The product launch of Cefaly DUAL was held at The Swiss Belhotel on 8th May in the presence of top Consultant Neurologists and leading health-care service providers in Bahrain. "We aim to provide a revolutionary treatment option to patients suffering from Migraine in Bahrain with the new technology in partnership with Cefaly Technology" said Mishal AbdulNabi Al Sho'ala, Chairman of Gulf Markets International W.L.L.
"We are extremely proud to announce today that Bahrain is only the second country in the world, after the USA , where the leading technology of Cefaly DUAL is made available for patients suffering from Migraine. The device is now available in Bahrain, carries a guarantee of two years and is well supported by an extensive network of after sales service of trained doctors and bio-medical engineers of Gulf Markets International W.L.L. Cefaly DUAL will provide a truly viable and Islamic option of an alternative treatment, without the need of taking any medication by mouth for the fasting patients in the holy month of Ramadan", said Alain Arida, CEO of Gulf Markets International W.L.L.