Vitaria vagal nerve stimulation system receives CE mark for treatment of chronic heart failure


Cyberonics has received CE mark of the Vitaria system for delivering autonomic regulation therapy 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 system is not available in the USA.

Results from the open-label ANTHEM-HF clinical study, presented at the European Society of Cardiology in 2014, show that patients treated with adjunctive autonomic regulation therapy 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 support the safety and efficacy of autonomic regulation therapy delivered by the Vitaria system-heart failure symptoms, as well as ventricular function, significantly improved,” says Inder Anand, former director of heart failure program at the VA Medical Center in Minneapolis, USA.

“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.”

“Autonomic regulation therapy heralds the dawn of a new chapter in neurocardiology-an era in which device-based autonomic therapies will reshape the field of cardiology,” says Jeffrey L Ardell, director of the Neurocardiology Research Center of Excellence at UCLA in Los Angeles, USA.

“The Vitaria system includes an implantable pulse generator, vagus nerve lead, programming system and patient kit that have been specifically designed to deliver autonomic regulation therapy in a manner that promotes improvements in heart function and reduces symptom expression,” says Bruce H Ken Knight, vice president of emerging therapies at Cyberonics. “Our mechanistic understanding of autonomic regulation therapy 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.”