PARIS — The complexity of the problems in mitral valve replacement are on the order of several magnitudes greater than with aortic valves. Which is why it becomes important to report these very early experiences, said William Wijns, chairman and course director of EuroPCR.

The general public might think of FDA and CMS as ingredients in the government’s alphabet soup, but there are times when things seem to move too slowly for a mere broth to be the medium. Here are two stories that are taking a lot of time to achieve the required viscosity. First, let’s tackle some of the blowback attached to FDA’s latest attempt to finesse the First Amendment on the point of off-label use. Off-label device use has been the bane of FDA for years, and...