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.
GAITHERSBURG, Maryland — The FDA general and plastic surgery devices panel yielded a 6-4 vote that the benefits outweigh the risks associated with the TissuGlu internal surgical adhesive by Cohera Medical (Pittsburgh) in wound care closure. The application breezed through the vote on whether the data indicated the device is safe by 11-0, but the efficacy vote narrowly favored the device at 6-5. The tight benefit/risk vote was driven in part by what the panelists said was an overly broad indications as well as by what several panelists characterized as an inadequate pivotal trial design.