суббота, 3 марта 2012 г.

FDA advisory panel recommends approval of depression device.

2004 JUL 12 - (NewsRx.com & NewsRx.net) -- Cyberonics, Inc., (CYBX) announced that the Neurological Devices Panel of the U.S. Food and Drug Administration's (FDA) Medical Devices Advisory Committee voted 5 to 2 to recommend approval with conditions of Cyberonics' VNS Therapy System "as an adjunctive long-term treatment of chronic or recurrent depression for patients over the age of 18 who are experiencing a major depressive episode that has not had an adequate response to four or more adequate antidepressant treatments."

Regarding conditions, the Panel recommended several labeling changes, that the VNS depression prescribers and implanting surgeons have appropriate experience …

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