Mi*****es have been a challenging condition to treat, often requiring patients to take powerful ***** with substantial side effects. **w the FDA has given the first permission to Market a device in the U.S. to help prevent the onset of mi*****es. The Cefaly from*STX-Med out of*Liege, Belgium is a **n-invasive Headband that delivers*transcutaneous electrical nerve stimulation (TENS) to the*trigeminal nerve k**wn to be involved in pathophysiology of Mi*****e headaches. The device is worn for up to 20 minutes per day and is indicated for Mi*****e sufferers 18 years of age or older. As with other TENS devices, there might be a tingling sensation and a muscle may even contract on its own in the head.
The device was cleared through FDA’s*de **vo review process for low risk devices that can’t go through the 510(k) substantial equivalence standard. Results of a study of 67 patients in Belgium with mi*****es that don’t take ***** to treat the condition, as well as a satisfaction survey from more than two thousand users in France and Belgium led to the FDA’s positive review of the Cefaly. Here’s a company view explaining the product:
03-13-2014, 08:34 PM
Cefaly Mi*****e Preventing TENS Headband Coming to U.S. Market (VIDEO)
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