Healthcare Industry News: U.S. Food and Drug Administration
News Release - September 21, 2017
FDA Releases Cefaly(R) for Acute Treatment of Migraine AttacksNEW YORK, Sept. 21, 2017 -- (Healthcare Sales & Marketing Network) -- CEFALY Technology announces today that on Friday, September 15th, the U.S. Food and Drug Administration (FDA) released the use of a new Cefaly® medical device for the acute treatment of migraine, with or without aura, in patients 18 years of age or older. The Cefaly Acute® will allow migraine patients to use the device during a migraine attack; making Cefaly® medical technology more than a mere preventive measure.
This means that Cefaly®, which was 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. A small percentage of migraineurs that experience very frequent migraine attacks need a prophylaxis and were using Cefaly medical technology to prevent their migraines. Now with the Cefaly Acute® program all migraineurs can benefit from this technology, which makes the market size ten times bigger for the company.
"We are excited that our medical technology is unique and can treat a migraine as well as prevent a migraine," said Dr. Pierre Rigaux, the chief executive officer 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 without medication and with next-to-no side effects."
The proprietary Cefaly technology has been improved using specific parameters to efficiently and safely address the different phases of migraines. Several recent clinical trials demonstrated that one hour of e-TNS with the Cefaly Acute® can relieve or stop the migraine headache. Results from the ACME (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%. In addition, 32% of patients were pain free within an hour.
Cefaly Acute® is expected to be available to patients in the next few months.
About CEFALY Technology
CEFALY Technology is a Belgium-based company, with US offices based in Wilton, Connecticut, specializing in electronics for medical applications. It has developed external cranial stimulation technology for applications in the field of neurology; in particular for treating migraines. For more information, visit http://www.cefaly.us. Find Cefaly on Twitter: @Cefaly and on Facebook: http://www.facebook.com/CefalyEN.
Source: CEFALY Technology
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