HOUSTON, Feb. 25, 2015 /PRNewswire/ -- Cyberonics, Inc. (NASDAQ: CYBX) today announced it received CE (Conformite Europeenne) Mark of the VITARIA™ System for delivering autonomic regulation therapy (ART) for patients who have moderate to severe heart failure (New York Heart Association (NYHA) Class II/III) with left ventricular dysfunction (ejection fraction < 40%), and who remain symptomatic despite stable, optimal heart failure drug therapy. The VITARIA System is not available in the United States.
Results from the open-label ANTHEM-HF clinical study, presented at the European Society of Cardiology in 2014, show that patients treated with adjunctive ART via vagus nerve stimulation for six months experienced clinically and statistically significant:
- improvement in heart pump function; average left ventricular ejection fraction increased from 32% at baseline to 37%;
- reduction in heart failure symptom burden; NYHA class improved at least one class in 77% of patients;
- improvement in quality of life (assessed by Minnesota Living with Heart Failure Questionnaire);
- increase in functional capacity (assessed by six-minute walk test); and
- improvement in autonomic regulation of heart rate and heart rate variability.
"The results of the ANTHEM-HF study, published in the November 2014 Journal of Cardiac Failure, support the safety and efficacy of ART delivered by the VITARIA System; heart failure symptoms, as well as ventricular function, significantly improved," said Inder Anand, M.D., D. Phil (Oxon), former director of heart failure program at the VA Medical Center in Minneapolis, Minnesota. "This new therapy engages the parasympathetic nervous system regulating cardiovascular function and acts synergistically with other treatment modalities used to manage chronic heart failure syndrome. By up-regulating central and peripheral parasympathetic neural activation, the well-known maladaptive effects of sympathetic hyperactivation can be reduced."
"ART heralds the dawn of a new chapter in neurocardiology – an era in which device-based autonomic therapies will reshape the field of cardiology," said Jeffrey L. Ardell, Ph.D., director of Neurocardiology Research Center of Excellence at UCLA in Los Angeles.
"The VITARIA System includes an implantable pulse generator, vagus nerve lead, programming system and patient kit that have been specifically designed to deliver ART in a manner that promotes improvements in heart function and reduces symptom expression," said Bruce H. KenKnight, Ph.D., Vice President of Emerging Therapies at Cyberonics. "Our mechanistic understanding of ART is based on decades of insightful neurocardiology research and has facilitated development of cardioprotective dosing regimens. We look forward to bringing this exciting therapeutic treatment option to cardiologists and patients in selected European markets soon."
About Autonomic Regulation Therapy (ART)
ART increases parasympathetic activity and thereby counteracts the sympathetic hyperactivation that is known to commonly occur as a compensatory response to heart damage resulting from myocardial infarction or chronic hypertension. Autonomic regulation of heart function reflects the interactions between sympathetic (fight or flight response) and parasympathetic (rest, relax response) elements of the autonomic nervous system. In the absence of heart failure pathology, the sympathetic and parasympathetic nervous systems work together to tightly regulate appropriate cardiovascular function in response to stresses encountered during normal activities of daily living.
About Cyberonics, Inc. and the VNS Therapy® System
Cyberonics, Inc. is a medical device company with core expertise in neuromodulation. The company develops and markets the VNS Therapy® System, which is FDA-approved for the treatment of medically refractory epilepsy and treatment-resistant depression. The VNS Therapy System includes an implanted pulse generator, similar to a pacemaker, that delivers mild electrical stimulation to the vagus nerve. Cyberonics offers the VNS Therapy System in selected markets worldwide.
The VITARIA™ System for delivering autonomic regulation therapy is now approved for commercial use in Europe, but is not FDA-approved, or available in U.S.
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 regulatory approval and commercial introduction of the VITARIA System for ART. 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 the VNS Therapy System and sales of our products; the development and satisfactory completion of clinical studies; the achievement of regulatory approval for ART; adverse changes in coverage or reimbursement amounts by the Centers for Medicare & Medicaid Services, state Medicaid agencies and private insurers; the presence or absence of intellectual property protection and potential patent infringement claims by competitors; maintaining compliance with government regulations; 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 25, 2014 and our Quarterly Report on Form 10-Q for the fiscal quarters ended July 25, 2014 and October 24, 2015.
Greg Browne, CFO Cyberonics, Inc. 100 Cyberonics Blvd. Houston, TX 77058 Main: (281) 228-7262 / Fax: (281) 218-9332 firstname.lastname@example.org
SOURCE Cyberonics, Inc.