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Montefiore Participates in Worldwide Clinical Trial for the Treatment of Heart Failure

One of the First Institutions in the U.S. to Enroll Patients

New York City, NY (October 13, 2011) - Montefiore Medical Center is one of the first institutions in the United States to participate in a clinical trial to determine the safety and efficacy of an implantable electrical stimulation device, designed to improve heart function in patients with Heart Failure, or HF.  The study, called INOVATE-HF, will evaluate the device's  ability to reduce hospitalization and death among patients with HF, while also exploring whether combined treatment with the implantable device and prescription drug therapy is more effective than drug therapy alone.

"The use of this stimulation device in patients with Heart Failure is part of our Center's effort to find novel therapies to improve the quality of life of our patients with HF," said Simon Maybaum, MD, associate professor of Cardiology and Medical Director of the Einstein Montefiore Center for Advanced Cardiac Therapy. "This therapy is intended for patients who remain symptomatic, despite conventional treatments for HF."

"The Montefiore Einstein Center for Heart and Vascular Care is deeply committed to finding new ways to fight the nation's number one killer, heart disease," said Robert Michler, MD, Chairman of the Department of Cardiovascular and Thoracic Surgery, as well as Surgeon-in-Chief, at Montefiore Medical Center.  "Through innovative clinical trials, we are certain that future discoveries are within our grasp."

Heart Failure is a serious condition in which the heart is unable to provide adequate blood flow to the body.  Affecting approximately 23 million people worldwide, two million new HF cases are diagnosed each year.  HF is one of the fastest growing heart conditions in this country and is caused by a variety of factors that result in damaged heart muscle, the most common of which are coronary artery disease, prolonged high blood pressure and heart valve disorders.

One of the hallmarks of HF is an imbalance in the autonomic nervous system. This imbalance leads to added stress on the heart and progressive deterioration of cardiovascular function. The implantable device, called the CardioFitÒsystem, is being tested to restore balance by activating a specific part of the nervous system (called the "parasympathetic" nervous system) to reduce stress on the heart thereby alleviating HF symptoms and reversing HF deterioration. It operates by stimulating the vagus nerve on the right side of the neck.

The CardioFit system consists of a stimulator, a sensor lead and a stimulation lead, which are implanted under the skin of the chest. The sensor lead is extended from the stimulator to the right ventricle of the heart, and the stimulation lead is extended from the stimulator to the vagus nerve on the right side of the neck. Once activated, the stimulator's electrical pulses are transferred via the stimulation lead to the vagus nerve. At the same time, the sensor lead monitors changes in heart activity and turns stimulation on or off accordingly. Like a pacemaker, the CardioFit system can be programmed on and off via external wireless communication with the device.

The safety and performance of the CardioFit system has been evaluated in a 32-patient, multi-center, pilot clinical study conducted in Germany, Italy, The Netherlands and Serbia.  The current multi-site clinical trial in Europe and the U.S. is enrolling patients who have been diagnosed with HF and are being treated with a combination of medicines, but who continue to have symptoms such as shortness of breath and fatigue.