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Oct. 24, 2011 /PRNewswire/ -- Cyberonics, Inc. (NASDAQ:CYBX), a global leader in devices for epilepsy management, announced today that it has submitted applications to both the U.S. Food and Drug Administration (FDA) and its European notified body, DEKRA Certification, B.V., for the re-design of its AspireHC generator, which was the subject of a voluntary product withdrawal on
August 15, 2011.
"Patient safety continues to be our first priority. Our product development team identified the cause of the problem and then implemented and tested the solution," said
Dan Moore, President and Chief Executive Officer. "We will work closely with regulatory bodies throughout the review process as necessary, but at this time, we don't know when the reviews will be completed.
"We anticipate re-submission of the AspireSR™ generator for ethics committee and competent authority approvals for the resumption of the E-36 clinical trial in
Europe no later than the end of fiscal 2012."
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 a medical device that delivers electrical pulsed signals to the vagus nerve. Cyberonics markets the VNS Therapy System in selected markets worldwide.
Additional information on Cyberonics and the VNS Therapy System is available at
Safe harbor statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. These statements can be identified by the use of forward-looking terminology, including "may," "believe," "will," "expect," "anticipate," "estimate," "plan," "intend," "forecast," or other similar words. Statements contained in this press release are based on information presently available to us and assumptions that we believe to be reasonable. We are not assuming any duty to update this information if those facts change or if we no longer believe the assumptions to be reasonable. Investors are cautioned that all such statements involve risks and uncertainties, including without limitation, statements concerning obtaining FDA and CE mark approval of our AspireHC generator and re-submission the AspireSR generator for ethics committee and competent authority approvals in
Europe by the end of fiscal 2012. Our actual results may differ materially. Important factors that may cause actual results to differ include, but are not limited to: continued market acceptance of VNS therapy and sales of our products; satisfactory completion of post-market studies required by the U.S. Food and Drug Administration as a condition of approval for the treatment-resistant depression indication; adverse changes in coverage or reimbursement amounts by third-parties; intellectual property protection and potential patent infringement claims; potential litigation relating to compliance with laws and regulations pertaining to our business; product liability claims and potential litigation; reliance on single suppliers and manufacturers for certain components; the accuracy of management's estimates of future expenses and sales; the potential identification of material weaknesses in our internal controls over financial reporting; and other risks detailed from time to time in our filings with the Securities and Exchange Commission (SEC). For a detailed discussion of these and other cautionary statements, please refer to our most recent filings with the SEC, including our Annual Report on Form 10-K for the fiscal year ended
April 29, 2011, and Quarterly Report on Form 10-Q for the fiscal quarter ended
July 29, 2011.
Contact InformationGreg Browne, CFOCyberonics, Inc.100 Cyberonics Blvd.
Houston, TX 77058Main: (281) 228-7262Fax: (281) 218-9332
SOURCE Cyberonics, Inc.