George Cm Siontis, Bernadette Coles, Jonas D Häner, Laurna McGovern, Joanna Bartkowiak, J J Coughlan, Alessandro Spirito, Roberto Galea, Andreas Haeberlin, Fabien Praz, Daijiro Tomii, Tom Melvin, André Frenk, Robert A Byrne, Alan G Fraser, Stephan Windecker
BACKGROUND AND AIMS: The European Union Medical Device Regulation 2017/745 challenges key stakeholders to follow transparent and rigorous approaches to the clinical evaluation of medical devices. The purpose of this study is a systematic evaluation of published clinical evidence underlying selected high-risk cardiovascular medical devices before and after market access in the European Union (CE marking) between 2000 and 2021. METHODS: Prespecified strategies were applied to identify published studies of prospective design evaluating 71 high-risk cardiovascular devices in 7 different classes (bioresorbable coronary scaffolds, left atrial appendage occlusion devices, transcatheter aortic valve implantation systems, transcatheter mitral valve repair/replacement systems, surgical aortic and mitral heart valves, leadless pacemakers, subcutaneous implantable cardioverter-defibrillator)...
August 28, 2023: European Heart Journal