Comparison of the investigational device exemption and post-approval trials of the Melody transcatheter pulmonary valve.
Jacqueline KreutzerAimee K ArmstrongJonathan J RomeThomas M ZellersDavid T BalzerJeffrey D ZampiAllison K CabalkaAlexander J JavoisDaniel R TurnerRobert G GrayJohn W MooreShicheng WengThomas K JonesDanyal M KhanJulie A VincentWilliam E HellenbrandJohn P CheathamLisa J BergersenDoff B McElhinneyPublished in: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions (2021)
Hemodynamic and time-related outcomes in the PAS and IDE trials were generally similar, confirming the effectiveness of the Melody TPV with real-world providers. There were few significant complications and limited power to identify important differences in AEs. The lack of major differences in outcomes between the two studies questions the usefulness of mandated costly post-approval studies as part of the regulatory process for Class III medical devices.