The FDA approves the 3rd and largest phase of BioControl Medical’s investigational device exemption trial of the CardioFit vagal nerve stimulation device.
Israel and Minnesota-based BioControl Medical won FDA approval to proceed with the 3rd and largest phase of its INOVATE-HF trail, evaluating its CardioFit vagal nerve stimulation system in treatment of heart failure.
The global, multi-center trial aims to provide clinical data in support of BioControl’s premarket approval application for FDA clearance of the CardioFit system, according to a press release.