Damon Canfield is a principal in NPI, a Powell, Ohio-based consultancy that specializes in helping U.S. medical-products firms launch into the Chinese market or establish manufacturing there. NPI has offices in Shanghai and Guangzhou, China, as well as Hong Kong.
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...