US FDA Panel Votes 'No' On Barricade Implant To Stop Reherniation
Executive Summary
A US FDA Orthopedics Advisory Panel voted 8-5 that the benefits do not outweigh the risks of implanting Intrinsic Therapeutics Inc.' Barricade prosthesis based on safety concerns, in particular a tendency for the device to break and separate into the lumbar column post implantation. Also, some panel members were not convinced that the device would improve patient function or allow people to return to their jobs.