PR Newswire11.29.17
CEFALY Technology announces the release of two new U.S. Food and Drug Administration (FDA)-approved migraine treatment devices. Cefaly, 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 ACUTE can help rescue a migraine already in progress. The Cefaly DUAL is a device that combines the newly approved ACUTE treatment with its prophylactic predecessor, the Cefaly 2; now more appropriately renamed Cefaly PREVENT.
"We are excited that we can now offer migraine patients several drug-free options in their migraine care," said Dr. Pierre Rigaux, CEO of CEFALY Technology, and a member of the team that invented the device. "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 ACUTE 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 treatment reduced migraine pain by 65 percent. In addition, 32 percent of patients were pain free within an hour.
Proprietary Cefaly technology has been adapted to efficiently and safely address the different phases of migraines. There are now three treatment options: Cefaly PREVENT, a prophylaxis treatment; Cefaly ACUTE, a rescue treatment, and Cefaly DUAL, a device that combines both prevent and acute technologies.
Despite these differences, the devices are administered in the same 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. All Cefaly devices are available to adults by prescription-only.
The Cefaly ACUTE can help rescue a migraine already in progress. The Cefaly DUAL is a device that combines the newly approved ACUTE treatment with its prophylactic predecessor, the Cefaly 2; now more appropriately renamed Cefaly PREVENT.
"We are excited that we can now offer migraine patients several drug-free options in their migraine care," said Dr. Pierre Rigaux, CEO of CEFALY Technology, and a member of the team that invented the device. "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 ACUTE 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 treatment reduced migraine pain by 65 percent. In addition, 32 percent of patients were pain free within an hour.
Proprietary Cefaly technology has been adapted to efficiently and safely address the different phases of migraines. There are now three treatment options: Cefaly PREVENT, a prophylaxis treatment; Cefaly ACUTE, a rescue treatment, and Cefaly DUAL, a device that combines both prevent and acute technologies.
Despite these differences, the devices are administered in the same 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. All Cefaly devices are available to adults by prescription-only.