Medtronic plc recently announced new clinical data for the Harmony Transcatheter Pulmonary Valve (TPV) from its early feasibility study, showing improved hemodynamics from baseline and consistent valve performance at one year. Presented at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, the positive new data from the first-of-its-kind early feasibility study led the U.S. Food and Drug Administration (FDA) to also recently approve the initiation of a Pivotal Investigational Device Exemption (IDE) study to evaluate the valve’s safety and effectiveness.
