Dublin-based Medtronic plc has won an investigational device exemption for its Harmony transcatheter pulmonary valve, after completing an early feasibility study of the device in patients with congenital heart disease (CHD). According to cardiologist Lee Benson, a professor of pediatrics at the University of Toronto, Harmony should prove to be "a game-changer for this very large patient population," but he also said more sizes of the device are needed for these patients.