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Cyberonics Inc. (CYBX) Release: ANTHEM-HF Shows Autonomic Regulation Therapy Is Safe And Improves Heart Function In Patients With Chronic Heart Failure


6/25/2014 9:33:29 AM

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HOUSTON, Sept. 2, 2014 /PRNewswire/ -- Cyberonics, Inc. (NASDAQ: CYBX), today announced results from the ANTHEM-HF clinical study. Results of the study presented by a prominent heart failure specialist during a major European cardiology congress and concurrently published by the Journal of Cardiac Failure show Autonomic Regulation Therapy (ART) in patients with moderate to severe chronic heart failure and impaired heart function is safe, improves the heart's ability to pump blood, and reduces symptoms associated with chronic heart failure. More than six million people in Europe have chronic heart failure, a syndrome characterized by the heart's inability to pump sufficient blood to meet the metabolic demands of the body.

Results from the ANTHEM-HF clinical study were presented during a Hot Line Session at the European Society of Cardiology Congress and showed that heart failure (HF) patients on stable pharmacological therapy and treated with ART via vagus nerve stimulation experienced a clinically significant:

  • improvement in heart pump function; average left ventricular ejection fraction increased from 32% at baseline to 37% after 6 months of ART;
  • reduction in heart failure symptom burden; NYHA class improved in 77% of patients;
  • improvement in quality of life (assessed by Minnesota Living with HF Questionnaire);
  • increase in functional capacity (assessed by Six-minute walk distance); and
  • improvement in autonomic regulation of heart rate.

University of Minnesota Professor Inder Anand, M.D., DPhil (Oxon), Chair of the ANTHEM-HF clinical study steering committee and Director of the Heart Failure Program, VA Medical Center, Minneapolis, Minnesota, commented, "Despite decades of research targeting the pathophysiology of chronic heart failure and development of pharmacological treatments that impart significant benefits, heart failure remains a leading cause of disability and death. We are encouraged by the significant beneficial effects of Autonomic Regulation Therapy in heart failure patients with reduced ejection fraction represented by the ANTHEM-HF study cohort. Presentation of the results and simultaneous publication in the Journal of Cardiac Failure provide important details that should permit selection of many patients that may benefit from this therapy, which appears to work synergistically with drugs commonly prescribed in connection with published guidelines."

Sponsored by Cyberonics, the ANTHEM-HF study was a prospective, multi-center, open-label, clinical study of patients with New York Heart Association (NYHA) Class II and III heart failure, QRS complex interval less than 150 milliseconds, and reduced heart pumping function (ejection fraction less than 40%). According to investigators, patients enrolled in the study received optimal heart failure pharmacological therapy prior to and during the study.

Sixty patients at 10 clinical centers across India underwent implantation of a Cyberonics VNS Therapy® System randomized to either the right or left vagus nerve to assess the safety and efficacy of ART. Following titration (gradual adjustment of stimulation parameters), all patients received continuously-cyclic, low-intensity, natural-frequency ART. Safety was assessed throughout the study and outcome measures were assessed after three months and six months and compared to baseline values.

"Heart failure remains a difficult and challenging syndrome throughout the world, despite optimal medical management," commented Dan Moore, President and Chief Executive Officer of Cyberonics. "We are pleased that patients with chronic heart failure participating in the ANTHEM-HF study experienced meaningful improvements and benefited from our proven VNS technology platform that has been prescribed and implanted more than 100,000 times for the treatment of drug-resistant epilepsy over the past 20 years. Based on the ANTHEM-HF study results, we remain committed to completing the development and commercial introduction of our new VITARIA System for ART."

More than 20 million people are affected with chronic heart failure throughout the world. Patients with heart failure experience debilitating symptoms, such as shortness of breath and chronic fatigue. Heart failure is a progressive syndrome that requires attentive clinical management, including occasional hospitalization. Pharmacological therapy is standard of care; however, morbidity and mortality remain excessive.

The ANTHEM-HF study motivation, objectives, design and outcome measures were previously published in the Journal of Cardiac Failure, 2013; 19(9):655-60. ANTHEM-HF study results are published on-line in Journal of Cardiac Failure, September 2014.

About Autonomic Regulation Therapy

Autonomic Regulation Therapy increases parasympathetic activity and thereby counteracts the sympathetic hyperactivation that is known to commonly ensue 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, 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. When HF develops and the heart pumping function becomes impaired, the autonomic nervous system attempts to compensate by increasing sympathetic activation and reduced central outflow of parasympathetic activity. Initially, this "autonomic imbalance" helps maintain cardiac output (blood supply to body). However, prolonged sympathetic hyperactivation is associated with maladaptive cardiovascular responses that promote HF progression and inferior outcomes.

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 an implanted medical device that delivers electrical stimulation 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 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 quarter ended July 25, 2014.

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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