The story has been out for a while about transcatheter aortic valve replacement (TAVR), so maybe it's time to project into the future. Before we head there, however, we should revisit the past. The pivotal event in this story is the drug-eluting stent, a device that gave birth to what FDA's Bram Zuckerman, MD, described as the DES trauma. The DES story is twofold; rapid physician adoption and late-stent thrombosis (LST). FDA saw the rate of adoption as an unruly and harmful stampede because of LST, but...

I've attended more FDA advisory committee hearings than most and believe I have a decent grasp of how those hearings should go. It's true I'm no expert, but recent hearings for medical devices have gone in a direction that strikes me as odd. For instance, at the Jan. 11 meeting of the gastroenterology/urology devices committee, FDA's Herb Lerner, MD, addressed post-market study requirements for an application filed by Torax Medical of St. Paul, Minnesota. Among the items of discussion that day were quality-of-life scores for gastroesophageal reflux and measures of esophageal pH. Lerner said: “This is a very interesting...