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Article: Cyberonics, Inc. Receives FDA Approval for a 30 Patient Pilot Study of VNS as a Treatment for Chronic Migraine Headache; Up to 28 Million Americans Suffer from Migraine Headache.
- Article from:
- Business Wire
- Article date:
- July 19, 2001
CopyrightCOPYRIGHT 2001 Business Wire. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Business Editors & Health/Medical Writers
HOUSTON--(BUSINESS WIRE)--July 19, 2001
Cyberonics, Inc. (NASDAQ/NMS:CYBX) today announced that the United States Food and Drug Administration (FDA) has granted Cyberonics an Investigational Device Exemption (IDE) for a 30 patient pilot study to assess the preliminary safety and efficacy of Vagus Nerve Stimulation (VNS) with the Cyberonics NeuroCybernetic Prosthesis (NCP(R)) System in treating patients with chronic migraine headache.
Up to 30 patients at four study sites will be implanted with the NCP System and treated with left cervical (neck area) vagus nerve stimulation similar to the VNS being used ...