Cyberonics (cybx) epilepsy therapy recommonded Message Board

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Biotech / Medical : Cyberonics (cybx) epilepsy therapy recommonded

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From: mopgcw	9/23/2006 1:28:50 AM
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FDA Panel to Review Depression Device Friday September 22, 12:21 pm ET By Matthew Perrone, AP Business Writer FDA Sets Panel Meeting to Review Depression Device That Could Compete With Cyberonics WASHINGTON (AP) -- Cyberonics, maker of a medical device which treats major depression, could soon face competition from the small, privately held Neuronetics Inc. The Food and Drug Administration announced yesterday it will convene a panel of outside experts Oct. 31 to consider whether Neuronetics' Neurostar system should be approved for widespread use. While the agency is not bound to follow the panel's recommendation, its opinion is often important in FDA decisions. ADVERTISEMENT The Neurostar system uses magnetic pulses targeted at specific areas of a patient's brain to relieve major depression, according to Neuronetics. The company says its device could be marketed to the approximately 4 million depression patients who do not respond to drug therapy. Neuronetics says its device differs from Cyberonics' because it is not surgically implanted. Instead, doctors treat patients with the device in the office over the course of three to six weeks. Last year, Cyberonics' Vagus Nerve stimulator became the first device approved by the FDA to treat depression patients who do not respond to drug treatment. The pacemaker-like device is implanted in the chest and stimulates nerves in the neck to alleviate severe depression symptoms. The stimulator is also used to treat epilepsy and Cyberonics is studying potential uses in treating Alzheimer's, migraine and bulimia. Shares of Cyberonics fell 23 cents to $17.11 Friday in morning trading on the New York Stock Exchange.

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