October 31, 2011

Cyberonics Receives FDA Approval for Expansion of MRI Use With VNS Therapy® Systems

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."

http://ir.cyberonics.com/releasedetail.cfm?ReleaseID=619246