US-based medical device firm Cyberonics has received CE mark approval for its Vitaria system to treat patients with moderate to severe heart failure.
The Vitaria system has not yet obtained approval from the US Food and Drug Administration (FDA).
According to the company, the Vitaria system’s ANTHEM-HF study demonstrated that patients treated with adjunctive autonomic regulation therapy (ART) through vagus nerve stimulation for six months showed improvement in heart pump function and average left ventricular ejection fraction increased from 32% at baseline to 37%.
Cyberonics’ Emerging Therapies vice-president Bruce KenKnight said: "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.
"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."
Earlier, the company received FDA approval for VNS Therapy System to treat medically refractory epilepsy and treatment-resistant depression.
The VNS Therapy System features an implanted pulse generator, similar to a pacemaker, which offers electrical stimulation to the vagus nerve.