Cyberonics Announces Results From The E-36 Study Of VNS Therapy® Delivered By The AspireSR™ Generator
Investigators present results at the American Epilepsy Society (AES) meeting in Washington, DC
HOUSTON, Dec. 8, 2013 /PRNewswire/ -- Cyberonics, Inc. (NASDAQ: CYBX) announced today that results from the E-36 clinical study of the AspireSR generator were presented at the annual AES Meeting, taking place December 6-10 at the Walter E. Washington Convention Center in Washington, D.C.
Paul Boon, M.D., Ph.D., Senior Full Professor of Neurology and Director of Ghent Institute for Neuroscience at Ghent University presented results of the study entitled, "Vagus Nerve Stimulation Triggered by Cardiac-Based Seizure Detection, A Prospective Multicenter Study," on December 7, 2013. The study (NCT01325623) was designed to evaluate the performance and safety of the AspireSR generator and its IntelliSense™ cardiac-based seizure detection feature.
Prof. Boon and clinical research colleagues at 13 other European centers implanted a total of 31 patients with the investigational AspireSR generator, which provides "normal mode" VNS Therapy augmented by seizure response stimulation. After the implant procedure and initial stimulation adjustment period, patients were admitted to an epilepsy monitoring unit for up to five days and monitored to identify seizures and collect heart-rate data.
The study met its primary endpoint in that the AspireSR generator, with IntelliSense cardiac-based seizure detection, detected more than 80% of seizures accompanied by ictal tachycardia (heart-rate increase) at a range of programmable settings. The potential false detection rates were low. The detections occurred close, and in some cases prior, to seizure onset, which may improve the effectiveness of the therapy. In a clinical study evaluating 9,482 seizures, augmentation of VNS Therapy with manually-activated acute stimulation at seizure onset terminated 24% of seizures and diminished the severity or duration of another 38% of seizures1. The recently published evidence-based guideline update by the American Academy of Neurology on the use of VNS Therapy in epilepsy includes a recommendation that acute stimulation may be associated with seizure termination when used at the time of seizure auras2. The safety profile for the AspireSR generator is consistent with currently available VNS Therapy systems.
"The E-36 study demonstrated the accuracy of the cardiac-based seizure detection algorithm for seizures with heart rate changes," said Prof. Boon. "Triggering stimulation when a seizure is detected should benefit patients with refractory epilepsy given the evidence that on-demand stimulation using the magnet can acutely interfere with seizure activity."
"The AspireSR product represents an important milestone in Cyberonics' ongoing commitment to provide technologically-advanced device-based solutions for people with epilepsy. We believe the addition of the proprietary IntelliSense seizure-response feature will continue to advance VNS Therapy as a foundational therapy for patients with refractory epilepsy," said Dan Moore, President and CEO of Cyberonics.
1 Morris GL, et al. Epilepsy Behav 2003;(4):740-5
2 Morris GL, et al. Neurology 2013;DOI 10.1212/WNL.0b013e3182a393dl
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, 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.
Greg Browne, CFO
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Fax: (281) 218-9332
SOURCE Cyberonics, Inc.
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