Sorin Group Announces Enrollment of First Patients in the Vanguard Clinical Study

Sorin Group, (Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, announced today the first successful implants of the Equilia^TM 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, overstresses the heart and contributes to the worsening of heart failure¹.

By stimulating the vagus nerve, the Equilia system is expected to normalize 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 ^TM 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,” said Professor Albert Hagège, Head of the Cardiology Department at the Hôpital Européen Georges Pompidou (HEGP), Paris, France and principal investigator in the Vanguard study.

The implant procedures were coordinated by Dr. Eloi Marijon, electrophysiologist at HEGP. Patients are also enrolled in the study at the Université Catholique de Louvain (UCL) Hospital in Brussels, Belgium by Dr. Jean-Benoît Le Polain de Waroux, electrophysiologist.

"Our New Ventures organization 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”, said André-Michel Ballester, Chief Executive Officer, Sorin Group.

About Heart Failure

Heart failure is a chronic progressive disease in which the heart can no longer pump enough blood to meet the needs of the body. Heart failure is an undertreated cardiac condition that affects a large number of patients worldwide. An estimated 22 million people in Europe and the US suffer from heart failure and associated diseases such as sleep apnea, cardiac arrhythmia and diabetes. Not only does the disease have low survival rates, it also generates high hospital costs for the healthcare systems². Due to their unstable cardiac condition, heart failure patients have a very high hospital readmission rate³.

Implantable cardioverter defibrillators (ICDs), or Cardiac Resynchronization Therapy devices (CRT-D or CRT-P) may be indicated for some patients; however, the vast majority are not candidates for these therapies. Vagus nerve stimulation may offer a new device-based therapeutic option for these patients.

About Sorin Group

Sorin Group (www.sorin.com) is a global, medical device company and a leader in the treatment of cardiovascular diseases. The Company develops, manufactures, and markets medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders. With over 3,500 employees worldwide, the Company focuses on two major therapeutic areas: Cardiac Surgery (cardiopulmonary products for open heart surgery and heart valve repair or replacement products) and Cardiac Rhythm Management (pacemakers, defibrillators and non invasive monitoring to diagnose and deliver anti-arrhythmia therapies as well as cardiac resynchronization devices for heart failure treatment). Every year, over one million patients are treated with Sorin Group devices in more than 100 countries.

For more information, please visit www.sorin.com

¹ De Ferrari GM. Vagal Stimulation in Heart Failure. J Cardiovasc Trans Res, 7(2014), 310-320
² Lloyd-Jones D et al. Heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010;121:e46-215 Neumann T et al. Heart failure: the commonest reason for hospital admission in Germany: medical and economic perspectives. Dtsch Arztebl Int. 2009;106:269-75. Berry C et al. Economics of chronic heart failure. Eur J Heart Fail. 2001;3:283-91 Stewart S et al. The current cost of heart failure to the National Health Service in the UK. Eur J Heart Fail. 2002;4:361-71
³ Zannad F. et al. Heart failure burden and therapy. Europace. 2009, 11; v1-v9 Gheorghiade M., Pang PS. Acute heart failure syndromes. J Am Coll Cardiol 2009;53:557–73 Mosterd A., Hoes AW. Clinical epidemiology of heart failure. Heart 2007;93:1137-1146 Cowie M. et al. Acute heart failure - a call to action. Br J Cardiol 2013; 20(2):S1-S11 Mc Murray JJ.et al. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The task force for the diagnosis and treatment of acute and chronic heart failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012;33(14):1787-1847