BioControl Medical has received U.S. Food and Drug Administration (FDA) approval to begin the third and largest phase of INOVATE-HF (INcrease Of VAgal TonE in Heart Failure), a global, multi-center, investigational device exemption (IDE) clinical study of the company’s CardioFit system for heart failure. The approval, which is based on the FDA’s safety review of the first two successful completed phases, allows unconditional study expansion to full enrollment of 650 patients at 80 centers worldwide.