Sorin announces enrolment of first patients in the Vanguard clinical study

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Sorin has announced the first successful implants of the Equilia system in the Vanguard (Vagal nerve stimulation safeguarding heart failure patients) clinical study. The system is intended to treat heart failure by stimulating the vagus nerve.

Heart failure has been shown to be associated with an imbalance in the autonomic nervous system that controls cardiac activity. This imbalance, a reduction in parasympathetic activity and an increase in sympathetic activity, over-stresses the heart and contributes to the worsening of heart failure.

By stimulating the vagus nerve, the Equilia system is expected to normalise the autonomic imbalance. The Equilia system consists of a small device 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.

“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,” says Albert Hagège, head of the cardiology department at the Hôpital Européen Georges Pompidou, Paris, France, and principal investigator in the Vanguard study.

The implant procedures were coordinated by Eloi Marijon, electrophysiologist at Hôpital Européen Georges Pompidou. Patients are also enrolled in the study at the Université Catholique de Louvain Hospital in Brussels, Belgium, by electrophysiologist Jean-Benoît Le Polain de Waroux.

“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”, says André-Michel Ballester, chief executive officer of Sorin.