The FDA circulatory system devices panel voted narrowly that the benefits outweigh the risks for the Watchman left atrial appendage (LAA) closure device made by Boston Scientific (BSX; Boston, Massachusetts), putting FDA on the spot for a device the agency seems wary of, but which has won three affirmative votes at advisory hearings. The key issue arising from the hearing for both the agency and the sponsor is what to do with the device's indication for use. Read More
