GAITHERSBURG, Maryland Protocol violations are not unheard of in pivotal device trials, but the trial for the CardioMEMS (Atlanta) Champion heart monitoring system was badly violated by FDA's reckoning thanks to communication from the sponsor to study sites. However, the FDA circulatory systems advisory committee voted that the risk-benefit dynamic was not supported for the diagnostic as much because of concerns that real-world use of the device would not match the way the Champion diagnostic was utilized in the pivotal trial, rendering a 6-4 vote that the risk-benefit profile did not measure up. Read More
