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

Main Category: Medical Devices / Diagnostics
Also Included In: Epilepsy;  Depression;  Bipolar
Article Date: 14 Jul 2006 - 0:00 PDT

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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 http://www.cyberonics.com and http://www.vnstherapy.com.

Cyberonics, Inc.
http://www.cyberonics.com

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