HOUSTON, Feb. 20, 2014 /PRNewswire/ -- Cyberonics, Inc. (NASDAQ:CYBX) announced today the CE Mark (Conformité Européenne) approval in Europe for the AspireSR generator, the novel sixth-generation VNS Therapy generator.
The AspireSR generator provides the well-established benefits of VNS Therapy, coupled with a new feature – Automatic Stimulation in response to detection of a seizure. Proprietary technology enables the AspireSR generator to analyze relative heart rate changes to detect and respond to seizures. This technology is based on a growing body of evidence that seizures are often accompanied by an increase in heart rate (ictal tachycardia). With the Automatic Stimulation feature, the AspireSR generator better aligns stimulation with the clinical onset of a seizure.
Currently, patients experiencing VNS Therapy can use a hand-held magnet to activate stimulation manually when they anticipate the onset of a seizure. This on-demand stimulation has been shown to stop or shorten a seizure, reduce seizure severity, and improve or shorten the postictal (post-seizure) recovery period. The Automatic Stimulation feature of the AspireSR generator may benefit patients who experience seizures accompanied by ictal tachycardia and are unable to perform on-demand stimulation with the hand-held magnet, do not have a magnet available when needed, or experience a seizure while sleeping.
Results of the E-36 clinical study, which evaluated the performance and safety of the AspireSR generator, were presented at the American Epilepsy Society meeting in December 2013. The study met its primary performance endpoint, and the safety profile for the AspireSR generator is consistent with currently available VNS Therapy systems."A significant number of people living with refractory epilepsy experience heart rate changes during their seizures," stated Prof. Dr. med. Christian E. Elger, FRCP, Head of the Department of Epileptology at the University Hospital of Bonn, Germany. "AspireSR builds upon the VNS Therapy platform by providing a unique, innovative possible therapeutic option for these patients by automatically detecting and responding to seizures upon heart rate increase." "European approval of the AspireSR generator represents an important milestone in Cyberonics' ongoing commitment to provide technologically-advanced, device-based solutions for people with epilepsy," said Dan Moore, President and CEO of Cyberonics. "This new generator will be particularly helpful to VNS Therapy patients who are unable to use magnet-activated stimulation consistently. We believe the Automatic Stimulation feature will continue to advance VNS Therapy as a foundational therapy for people with refractory epilepsy." About Cyberonics, Inc. and VNS Therapy ® 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 an implanted medical device that delivers pulsed electrical signals to the vagus nerve. Cyberonics offers the VNS Therapy System in selected markets worldwide. Additional information on Cyberonics and the VNS Therapy System is available at www.cyberonics.com. 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 achieving an improved therapeutic effect from the AspireSR generator through Automatic Stimulation, obtaining regulatory approval and commercial release of the AspireSR generator, and advancing VNS Therapy as a foundational therapy for patients with refractory 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 products; the development and satisfactory completion of clinical studies and the regulatory approval of new products, including a VNS Therapy System for the treatment of other indications; satisfactory completion of the post-market registry 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 products and indications; product liability lawsuits and other litigation; reliance on single suppliers and manufacturers for certain components; the accuracy of management's estimates of future revenue and expenses; 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 26, 2013 and our Quarterly Report on Form 10-Q for fiscal quarters ended July 26, 2013 and October 25, 2013. Contact Information Greg Browne, CFOCyberonics, Inc.100 Cyberonics Blvd. Houston, TX 77058Main: (281) 228-7262Fax: (281) 218-9332 email@example.com SOURCE Cyberonics, Inc.
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