BOSTON, MA--(Marketwire - January 22, 2013) - Massachusetts General Hospital is evaluating a new treatment for heart failure in a clinical study to treat this condition through nerve stimulation in the neck.
"A growing body of researching is demonstrating that there is a connection between the heart and brain which could benefit heart failure patients," says Dr. Kimberly Parks, Massachusetts General Hospital, who is leading the study. "This is a new device that is the first to treat the heart through nerve stimulation, a completely new mechanism of action."
The INOVATE-HF clinical trial is a global investigational study to determine the overall effectiveness of the CardioFit® system for treating heart failure. CardioFit® is an implanted electrical device designed to improve heart function in patients with heart failure. It works by stimulating specific nerves that help regulate and reduce stress on the heart, easing heart failure symptoms and reversing deterioration.
The device is implanted under the skin of the chest and attached to the heart, like a pacemaker. It is also connected to a nerve in the neck. Electrical pulses from the device are sent to the nerve, which sends signals to the heart. The device is programmed by the patient's physician through a wireless connection, as is done with pacemakers.
"The safety and performance of CardioFit has been validated in previous clinical studies," said Dr. Parks. The INOVATE-HF is allowing physicians to investigate its potential benefits among a larger and diverse group of patients."
For more information, or for evaluation as a possible candidate to take part in the study, please call Heart Failure Clinical Trials at 617.643.2887.
About Heart Failure
HF currently affects approximately 23 million people worldwide and is diagnosed in two million new cases each year, according to World Market Research. The leading cause of hospitalization in people over age 65; HF is also the most rapidly growing cardiovascular disorder in the United States (American Heart Association). Most HF patients are treated with prescription drugs that are successful at managing select symptoms but are ultimately unable to stop HF deterioration. CardioFit was developed to address this unmet clinical need by directly activating a specific part of the body's 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 safety and performance of the CardioFit have been validated in a 32-patient, multi-center, pilot clinical study conducted in Germany, Italy, The Netherlands and Serbia. Study data showed that patients experienced sustained significant improvement across key clinical measures including left ventricular function and structure, heart rate variability, and resting heart rate. Patients also showed improvement in self-reported quality of life surveys and six-minute hall walk tests. The results of this pilot study supported BioControl Medical's filing for CE mark certification to market and sell CardioFit in the European Union, which it was granted in December 2008.