Italian medical device firm Sorin Group has started enrolment in its Vanguard (Vagal Nerve Stimulation Safeguarding Heart Failure Patients) clinical study, which is designed to evaluate Equilia, a neurostimulation system for heart failure patients.
Heart failure (HF) is a chronic progressive disease that occurs when the heart is unable to pump sufficiently to maintain blood flow to meet the needs of the body.
The disease was shown to be associated with an imbalance in the autonomic nervous system that controls cardiac activity, and this imbalance over stresses the heart and contributes to the worsening of heart failure.
Equilia system is intended to treat heart failure by stimulating the vagus nerve to normalise the autonomic imbalance.
The system includes a small device, which is implanted under the skin in the patient’s chest that delivers electrical pulses via the EquiCurl lead placed around the vagus nerve in the neck area.
Principal investigator in the Vanguard study professor Albert Hagège said: "Neurostimulation is expected to prolong heart failure patients’ survival, improve their quality of life and reduce the number of hospital readmissions.
"I believe the Equilia system has the potential to bring significant benefits to heart failure patients."
The company also announced completion of the first successful implants, and these procedures were coordinated by Hôpital Européen Georges Pompidou electrophysiologist Dr Eloi Marijon.
In the trial, patients were also enrolled at the Université Catholique de Louvain (UCL) Hospital in Brussels, Belgium by Dr Jean-Benoît Le Polain de Waroux, electrophysiologist.
Sorin Group CEO André-Michel Ballester said: "Our New Ventures organisation is actively working on several vagus nerve stimulation projects to treat heart failure disease.
"Equilia is New Ventures’ first innovation to enter clinical trials. Vagus nerve stimulation has the potential to expand the clinical indications for device-based therapies for heart failure, and we look forward to bringing this exciting new therapy to the market."
Implantable cardioverter defibrillators (ICDs), CRT-D or CRT-P (cardiac resynchronisation therapy devices) may be indicated for some HF patients. The company said that vagus nerve stimulation may offer a new device-based therapeutic option for these patients.