BioControl Medical, a privately held medical device company headquartered in Yehud, Israel with offices in New Hope, Minnesota, develops implantable medical devices to treat disorders of the autonomic nervous system. Our objective is to improve quality of life and longevity of patients suffering from heart failure.
According to the American Heart Association (AHA), heart failure and its complications are a leading cause of death and hospitalization worldwide, affecting over 23 million people. Heart failure alone is the leading cause of hospitalization for people over the age of 65 years, causes almost one million hospitalizations every year in the United States alone, and is responsible for more deaths than the 3 most common cancers combined.
Since 2003, BioControl Medical has focused on the development of the CardioFit® System for the treatment of heart failure. A European pilot study of the CardioFit System, published in October 2010 in the European Heart Journal, demonstrated that controlled stimulation of the vagus nerve helped reduce heart failure symptoms, and improved heart function, exercise capacity, and quality of life. It is the first device developed to treat the heart via direct vagus nerve stimulation.
Based on the experience gained in the European pilot study, BioControl Medical is sponsoring an international, multi-center, pivotal study of the CardioFit System. INOVATE-HF has enrolled a total of 725 patients at 86 centers in the United States and Europe, making it the largest prospective, randomized device study to evaluate the treatment of HF with vagus nerve stimulation.