BioControl expands IDE study for heart failure treatment device

BioControl Medical has nailed down crucial FDA approval to launch the third and largest phase of an IDE study for its CardioFit electrostimulation implant for treating heart failure. The device company (based in Minnesota and Israel) began its INOVATE-HF clinical trial in April 2011 under an investigational device exemption. Phase III of the ongoing study calls for expanding to full enrollment of 650 patients at 80 medical centers around the globe. Researchers will look at whether CardioFit can reduce hospitalization and death rates for heart failure patients, and also at whether CardioFit plus drug therapy works better than medication alone. CardioFit is an implantable electrical stimulation device focused on the vagus nerve. Release

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