Cyberonics Receives FDA Approval For Harmonized/Modularized VNS Therapy System Labeling Format

Cyberonics, Inc. (Nasdaq:
CYBX) today announced that it received FDA approval for a
harmonized/modularized VNS Therapy(TM) System labeling format and FDA
approval to market the VNS Therapy Model 250 Version 7.1.4 Programming
Software in the United States.


The new labeling format combines the previously separate pulse
generator manuals for the refractory epilepsy and treatment-resistant
depression indications into a single manual. This new combined manual, the
Pulse Generator Physician's Manual, includes all PMA-approved indications
and clinical information in a modular format so that any future updates or
expansions to the labeling will require amendments only to the specific,
affected module. Since many of the contraindications, warnings, precautions
and other information are the same for the pulse generator and the lead,
the modular approach has also been applied to the Model 302 Lead
Physician's Manual.


Cyberonics has also received FDA approval on modifications and
enhancements made to VNS Therapy, Model 250, Version 7.1.4 Programming
Software. This latest version of software is compatible with all approved
VNS Therapy generator models and has several features specifically designed
for the future DEMIPULSE(TM) (Model 103) single connector and DEMIPULSE
DUO(TM) (Model 104) dual connector generators.


"Harmonizing the labeling and providing it in a modular format will
help ensure that important product information is communicated to health
care providers in a consistent, informative, and user-friendly manner. It
will also make future labeling revisions easier to implement," said Richard
L. Rudolph, M.D., Cyberonics' Vice President, Clinical and Medical Affairs
and Chief Medical Officer. "The Version 7.1.4 Software is just the latest
step in Cyberonics' efforts to continually refine and improve VNS Therapy,"
continued Dr. Rudolph. "These latest FDA approvals represent the Company's
on-going commitment to assisting physicians in making informed treatment
decisions and providing the best care possible for their patients."


ABOUT VNS THERAPY AND CYBERONICS


Information on Cyberonics, Inc. and VNS Therapy is available at
cyberonics and vnstherapy.


Cyberonics, Inc.

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