Press release from PR Newswire
Cyberonics Receives FDA Approval for Expansion of MRI Use With VNS Therapy® Systems
Monday, October 31, 2011
Cyberonics Receives FDA Approval for Expansion of MRI Use With VNS Therapy® Systems09:00 EDT Monday, October 31, 2011HOUSTON, 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® SystemCyberonics, 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 the VNS Therapy System. Safe harbor statementThis 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 enabling VNS Therapy System patients to obtain access to the faster, higher resolution imaging and providing physicians with expanded imaging options for patients with epilepsy. 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 product; the development and satisfactory completion of clinical trials and/or market test and/or regulatory approval of VNS Therapy for the treatment of other indications; 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 infringement claims; maintaining compliance with government regulations and obtaining necessary government approvals for new indications; 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 results of the previously disclosed governmental inquiries; the potential identification of material weaknesses in our internal controls over financial reporting; risks and costs associated with such governmental inquiries and any litigation relating thereto or to our stock option grants, procedures, and practices 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 our Quarterly Report on Form 10-Q for the fiscal quarter ended July 29, 2011.Contact InformationGreg Browne, CFOCyberonics, Inc.100 Cyberonics Blvd.Houston, TX 77058Phone: (281) 228-7262Fax: (281) firstname.lastname@example.org SOURCE Cyberonics, Inc.