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. Read More
