CHICAGO – The FDA might not care that much for the opinions of device makers about when the data are enough to support device approvals, but physicians involved in a study of a third-generation TAVR device are arguing that the data for the Sapien 3 valve are enough to approve the device in intermediate-risk patients.

The Windy City really lived up to its name during the course of ACC 2016, didn't it? It was also interesting to hear the recording on the subway stating that gambling is not allowed on the trains. Who knew? ACC 2016 provided a lot of gist for the scribbling class, including some noise about operator volume requirements for TAVR devices. There was also pressure from physicians on FDA to approve the latest generation of devices based on data from other than the classic randomized trial, which in the past may or...