Extended Follow-Up Of ANTHEM-HF Patients Shows That Benefits Of Autonomic Regulation Therapy Are Maintained After 12 Months

HOUSTON, Sept. 28, 2015 /PRNewswire/ -- Cyberonics, Inc. (NASDAQ:CYBX), yesterday announced results from the extension of the ANTHEM-HF clinical study (ENCORE Study).  Results of the study presented by a prominent heart failure (HF) specialist during a major cardiology congress in the United States show that Autonomic Regulation Therapy (ART) in patients with moderate to severe chronic HF and impaired heart function is well tolerated, safe, improves the heart's ability to pump blood, and reduces the frequency and severity of symptoms associated with chronic HF.  More than 10 million people in the United States and Europe have chronic HF, a syndrome characterized by the heart's inability to pump sufficient blood to meet the metabolic demands of the body.

Results from the ENCORE clinical study were presented during a Late Breaking Clinical Trials Session at the 19th Annual Meeting of the Heart Failure Society of America (HFSA) and showed that patients with chronic, reduced ejection fraction HF on stable pharmacological therapy and treated with ART for 12 months via electrical stimulation of the cervical vagus nerve experienced a statistically and clinically significant:

  • improvement in heart pump function: average left ventricular ejection fraction increased from 33.2% at baseline to 39.5%; average left ventricular end-systolic volume decreased 10% from 102 ml to 92 ml;
  • reduction in HF symptom burden; NYHA class improved in 94% 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 resting heart rate.

University of Minnesota Professor of Medicine Inder Anand, M.D., DPhil (Oxon), Chair of the ANTHEM-HF clinical study steering committee and until recently Director of the Heart Failure Program, VA Medical Center, Minneapolis, Minnesota, commented, "Patients with heart failure continue to be at high risk of increased morbidity and mortality.  They need new therapies, such as ART, that work synergistically with evolving forms of drug therapy.  The results from the extension of the ANTHEM-HF study presented during a Late Breaking Clinical Trials Session at HFSA provide important insights into the safety and durability of ART (Autonomic Regulation Therapy).  During the 6- to 12-month follow-up period, none of the patients experienced serious adverse events related to ART, and the improvements in cardiac function both in terms of ejection fraction and reverse remodeling suggest that ART is ready to be tested in a randomized, control trial in which a larger cohort of optimally-managed chronic HF patients from the US and the EU would be randomized to a treatment group and a control group to more extensively evaluate safety and efficacy."

Sponsored by Cyberonics, the ENCORE study was a prospective, multi-center, open-label, extension of the ANTHEM-HF study during which the effects of ART were evaluated in chronic HF 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 (left ventricular ejection fraction less than 40%).  According to investigators, patients enrolled in the study received optimal HF pharmacological therapy prior to and during all phases of study.

Forty-nine patients previously enrolled in the ANTHEM-HF study elected to participate in the ENCORE study and received ART for an additional 6 months (12 months total).  All patients received continuously-cyclic, natural-frequency ART previously described in the publication of ANTHEM-HF results.  Safety was assessed throughout the ENCORE study and outcome measures were assessed after 12 months of ART and compared to baseline values of the ENCORE cohort.

"Chronic heart failure syndrome is a leading cause of death and imposes a significant burden on health care systems throughout the world," commented Rohan Hoare, Chief Operating Officer of Cyberonics.  "We continue to be encouraged by the clinical benefits associated with ART and presented by the investigators.  Based on the ANTHEM-HF and ENCORE study results, we plan to expand the commercial introduction of our VITARIA System (www.VITARIAsystem.com) in Europe and are in planning stages for additional clinical studies."

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.

ANTHEM-HF study results are published in the Journal of Cardiac Failure, 2014; 20:808-16.

About Autonomic Regulation Therapy

Autonomic Regulation Therapy (ART) 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 the conduct of additional clinical studies for the Vitaria System for ART and expansion of the commercial introduction of the VITARIA System.  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 24, 2015 and our Quarterly Report on Form 10-Q for the fiscal quarter ended July 24, 2015.

Contact Information

Greg Browne, CFO
Cyberonics, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
Main:  (281) 228-7262 / Fax:  (281) 218-9332


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SOURCE Cyberonics, Inc.

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