Cyberonics announces CE Mark Approval of the VITARIA™ System for Treatment of Chronic Heart Failure

Thursday, February 26, 2015

Cyberonics, Inc. 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.


Source :