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Cyberonics Receives FDA Approval for Expansion of MRI Use With VNS Therapy® Systems
Date:10/31/2011

HOUSTON, Oct. 31, 2011 /PRNewswire/ -- Cyberonics, Inc. (NASDAQ: CYBX), a global leader in medical devices for the treatment and management of epilepsy, today announced that the U.S. Food and Drug Administration ("FDA") approved a significant expansion of options for Magnetic Resonance Imaging ("MRI") use by patients who have the VNS Therapy System.

The expansion includes:

  • New: All cylindrical MRI scanners with magnetic field strengths of 3.0 and 1.5 Tesla; Previous: GE Signa 1.5 Tesla scanner only
  • New: Imaging of head and extremities, including knees, using transmit/receive coils; Previous: head imaging only using transmit/receive coils

"This approval will enable VNS Therapy System patients to obtain access to the faster, higher resolution imaging available with 3.0 Tesla MRI scanners," commented Dan Moore, Cyberonics' President & Chief Executive Officer.  "Our VNS technology, coupled with this approval, provides physicians with expanded imaging options for patients with epilepsy.

"We are pleased that the FDA has been responsive to patient needs and granted this approval."

About Cyberonics, Inc. and the VNS Therapy® System

Cyberonics, Inc. is a medical technology company with core expertise in neuromodulation.  The company developed and markets the VNS Therapy System, which is FDA-approved for the treatment of refractory epilepsy and treatment-resistant depression.  The VNS Therapy System uses an implanted medical device that delivers electrical pulsed signals to the vagus nerve.  Cyberonics markets the VNS Therapy System in selected markets worldwide.

A full description of the revised MRI labeling will be available at www.cyberonics.com, along with additional information on Cyberonics and th
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SOURCE Cyberonics, Inc.
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