Cyberonics Announces First Implant of AspireSRâ„¢ Seizure Response Product in European Trial
May 2nd, 2011 // 2:48 pm @ jmpickett
HOUSTON, May 2, 2011 /PRNewswire/ — Cyberonics, Inc. (Nasdaq: CYBX), a global leader in epilepsy management, today announced the first implant of its AspireSRâ„¢ seizure response product on April 27, 2011.
The implant, conducted under the care of Professors Paul Boon and Dirk Van Roost and their teams at the Ghent University Epilepsy Group in Ghent, Belgium, was received by a patient with ictal tachycardia (heart rate increases associated with seizures) who has been suffering with epilepsy for many years.
The company’s approved products allow the patient to induce additional stimulation manually through the use of a magnet, but do not currently sense the onset of seizures. The AspireSR product automates the magnet stimulation by sensing heart rate changes that are correlated with the patient’s seizure activity. The generator then provides stimulation of the vagus nerve in response to the seizure.
“This is an important milestone in the development of treatments for epilepsy, a particularly challenging condition affecting almost three million people in the U.S., and corresponding numbers worldwide,” said Dan Moore, Cyberonics’ President and Chief Executive Officer. “It also represents significant progress in our development of improvements to the VNS Therapy® System. We look forward to completing the enrollment of this clinical trial, E-36.”
“We are pleased to be able to initiate the first implant of this new product,” said Professor Boon. “The design is consistent with existing VNS devices, and the procedure was conducted in the usual manner, but the ability of the device to sense changes correlated with a seizure and induce responsive stimulation of the vagus nerve is unique. The new device will be particularly significant for patients who are unable to use a magnet for additional stimulation.”
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 surgically implanted 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 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 enrolling and completing our E-36 clinical study, obtaining regulatory approval for our AspireSR device, and achieving incremental benefits from our AspireSR device over our currently approved products . 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 30, 2010, and our Quarterly Reports on Form 10-Q for the fiscal quarters ended July 30, 2010, October 29, 2010 and January 28, 2011.
Contact Information
Greg Browne, CFO
Cyberonics, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
Main: (281) 228-7262
Fax: (281) 218-9332
ir@cyberonics.com
SOURCE Cyberonics, Inc.
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