NEW YORK, Jan. 20, 2015 /PRNewswire/ -- Cefaly® the first device of its kind to receive U.S. Food and Drug Administration (FDA) approval for the preventative treatment of migraine headaches ends 2014 with more than 10,000 satisfied patients in the United States. This symbolic milestone, illustrates that Cefaly® has indeed found a way to help migraineurs control, even eliminate, their migraines.
"We are excited to bring drug-free migraine relief to so many patients in the United States in such a short amount of time," said Dr. Pierre Rigaux, the chief executive officer of CEFALY Technology, the Belgian maker of the device and a member of the team of inventors.
The FDA approved Cefaly® for the preventative treatment of migraine headaches mid-March. At that time, it reached its decision using data from a randomized double blinded clinical trial implemented in five university clinics in Belgium; as well as a patient satisfaction study of 2,313 Cefaly® users in France. This newly available U.S. data of more than 10,000 patients shows more than a 94% success rate, with less than 6% of patients returning their units after a 60-day trial period; worldwide there are more than 100,000 Cefaly units in use by migraine patients.
Several thousand physicians in the US have now prescribed Cefaly; both doctors and patients have described the enormity of relief as a top reason for its demand.
"The Cefaly device has been a great option as a headache preventative with almost no side effects and significant improvement in headache frequency," said Dr. Cori Millen, owner and medical director of Summit Headache and Neurologic Institute in Englewood, Colorado. We have been very pleased with finally having the option to add neuro-stimulation as a treatment regimen."
Cefaly® is the first transcutaneous electrical nerve stimulation device specifically authorized for use prior to the onset of migraine pain. The battery-powered device is worn for 20-minutes a day. It resembles a headband and uses tiny electrical impulses to stimulate the trigeminal centers to reduce the frequency and intensity of migraines.
In December, Cefaly® opened an office in Connecticut, which serves as the exclusive distributor of Cefaly® in the U.S, and contracted warehouse in Pennsylvania. Previously orders shipped from the company's headquarters in Belgium.
Cefaly® costs $349 plus $15 shipping and handling. The electrodes needed to operate the device cost $25 for a set of three (each electrode will last for up to approximately 20-uses). There is a 60-day money back guarantee. A medical prescription is needed to purchase the device, available at www.Cefaly.us. For assistance call (203) 309-5670.
About CEFALY Technology
CEFALY Technology is a Belgium-based company 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. www.Cefaly.us
Media Contact: Maria Coder
SOURCE CEFALY Technology