GAITHERSBURG, Maryland The application by Medtronic (Minneapolis) to expand the indication for one class of its electrophysiology hardware for class II heart failure patients turned out well at Wednesday's advisory committee hearing despite a lot of negative rhetoric by members of the advisory committee. The firm earned a 3-2 final vote that the benefits of the firm's devices for this indication outweigh the risks, and the vote may have struck some observers as a surprise given the obvious antipathy toward the application's supporting studies by some members of the panel. However, the FDA representatives who argued the agency's case seemed none too fond of the application, either. Read More
