January 15, 2016 — The U.S. Food and Drug Administration (FDA) has given its approval for an expanded indication study of Edwards' Sapien 3 valve in low-risk patients. This will be the first U.S. study of a transcatheter aortic valve replacement (TAVR) device in this patient population, which would normally receive an open-heart surgical valve replacement. If TAVR proves to be at least equal in outcomes to surgery, it will likely cause a paradigm shift in the standard of care.