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The last 5 uploaded publications
Defining device success for percutaneous coronary intervention trials: a position statement from the European Association of Percutaneous Cardiovascular Interventions of the European Society of Cardiology
Chun Chin Chang, Norihiro Kogame, Yoshinobu Onuma, Robert A. Byrne, Davide Capodanno, Stephan Windecker, Marie-Angèle Morel, Donald E. Cutlip, Mitchell W. Krucoff, Gregg W. Stone, Alexandra J. Lansky, Roxana Mehran, Ernest Spitzer, Alan G. Fraser, Andreas Baumbach, Patrick W. Serruys (2020). Defining device success for percutaneous coronary intervention trials: a position statement from the European Association of Percutaneous Cardiovascular Interventions of the European Society of Cardiology. EuroIntervention, 15(13), pp. 1190-1198, DOI: 10.4244/eij-d-19-00552.
Article341 days agoStandardized assessment of evidence supporting the adoption of mobile health solutions: A Clinical Consensus Statement of the ESC Regulatory Affairs Committee
Enrico G. Caiani, Hareld Kemps, Petra Hoogendoorn, Riccardo Asteggiano, Allan Böhm, Britt Borregaard, Giuseppe Boriani, Hans‐Peter Brunner‐La Rocca, Rubén Casado-Arroyo, Silvia Castelletti, Ruxandra Christodorescu, Martín Cowie, Paul Dendale, F. Dunn, Alan G. Fraser, Deirdre A. Lane, Emanuela H. Locati, Katarzyna Małaczyńska-Rajpold, Caius Ovidiu Merșa, Lis Neubeck, Gianfranco Parati, Chris Plummer, Giuseppe Rosano, Martijn Scherrenberg, Amie Smirthwaite, Piotr Szymański (2024). Standardized assessment of evidence supporting the adoption of mobile health solutions: A Clinical Consensus Statement of the ESC Regulatory Affairs Committee. , 5(5), DOI: https://doi.org/10.1093/ehjdh/ztae042.
Article2 days agoQuality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review
Lotje A. Hoogervorst, Timon H. Geurkink, Anne Lübbeke, Sergio Buccheri, Jan W. Schoones, Marina Torre, Paola Laricchiuta, Paul Piscoi, Alma B Pedersen, Chris P Gale, James Smith, Aldo Maggioni, Stefan James, Alan G. Fraser, Rob G. H. H. Nelissen, Perla J. Marang‐van de Mheen (2023). Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review. , 12, DOI: https://doi.org/10.34172/ijhpm.2023.7648.
Article2 days agoRecommended methodologies for clinical investigations of high-risk medical devices—Conclusions from the European Union CORE–MD Project
Alan G. Fraser, Sergio Buccheri, Robert A. Byrne, Per Kjærsgaard‐Andersen, Stefan James, Peter Jüni, Lia Bally, Richard Bulbulia, Berthold Koletzko, Martin Landray, Claudia Louati, Anne Lübbeke, Perla J. Marang‐van de Mheen, Peter McCulloch, Bernadeta Patro-Gołąb, Frank Rademakers, Petra Schnell‐Inderst, George C.M. Siontis, Marina Torre, Claudia Wild, Yasemin Zeisl, Tom Melvin, Rob G. H. H. Nelissen, Piotr Szymański, Chris P Gale, Aldo Maggioni, Chris Wilkinson, Fábio Santos Santana, Valentina Tageo, Jean-Baptiste Rouffet, Adrian Ott, Elizabeth Macintyre, Marieke Meijer, Loredana Simulescu, Kathrin Guerlich, Hannes Jarke, Valentina Strammiello, Lotje A. Hoogervorst, Ewout W. Steyerberg, Jasper W.A. van Egeraat, Alma B Pedersen, William Plath, Baptiste Vasey, Marion Mafham, Louise Bowman, James Smith, Christophe Combescure, Christophe Baréa, Jonas Oldgren, Laurna McGovern, J J Coughlan, Rory Durand, Stephan Windecker, Andrè Frenk, Bernadette Coles, Arjola Bano, Juri Künzler, Faina Wehrli, Lum Kastrati, Markus Laimer, Elisabetta Biasin, Erik Kamenjašević, J. Gary Meszaros, Isabelle Huys, Pascal Borry, Ursula Rochau, Tanja Planinschitz, Uwe Siebert, David Epstein, John Eric Chaplin, Ola Rolfson, Enrico G. Caiani, Yijun Ren, Donal B O’Connor, Gearóid McGauran, G. A. O’Connor, Niall MacAleenan, Sanjeev Yoganathan, Jan Szulc, Robert E. Geertsma, Jantine W.P.M. van Baal, Paola Laricchiuta, E. Carrani, Stefania Ceccarelli, Enrico Ciminello, Sabine Ettinger, Juan Antonio Blasco‐Amaro, Agnieszka Dobrzynska, Jesús Aranda, Juan Carlos Rejón-Parrilla, Françoise Schlemmer, Sabina Hoekstra, Richard Holborow, Marianna Mastroroberto, Erman Melikyan, Alexey Shiryaev, Christoph Ziskoven (2025). Recommended methodologies for clinical investigations of high-risk medical devices—Conclusions from the European Union CORE–MD Project. , 58, DOI: https://doi.org/10.1016/j.lanepe.2025.101460.
Article2 days agoRecommended methodologies for clinical investigations of high-risk medical devices—Conclusions from the European Union CORE–MD Project
Alan G. Fraser, Sergio Buccheri, Robert A. Byrne, Per Kjærsgaard‐Andersen, Stefan James, Peter Jüni, Lia Bally, Richard Bulbulia, Berthold Koletzko, Martin Landray, Claudia Louati, Anne Lübbeke, Perla J. Marang‐van de Mheen, Peter McCulloch, Bernadeta Patro-Gołąb, Frank Rademakers, Petra Schnell‐Inderst, George C.M. Siontis, Marina Torre, Claudia Wild, Yasemin Zeisl, Tom Melvin, Rob G. H. H. Nelissen, Piotr Szymański, Chris P Gale, Aldo Maggioni, Chris Wilkinson, Fábio Santos Santana, Valentina Tageo, Jean-Baptiste Rouffet, Adrian Ott, Elizabeth Macintyre, Marieke Meijer, Loredana Simulescu, Kathrin Guerlich, Hannes Jarke, Valentina Strammiello, Lotje A. Hoogervorst, Ewout W. Steyerberg, Jasper W.A. van Egeraat, Alma B Pedersen, William Plath, Baptiste Vasey, Marion Mafham, Louise Bowman, James Smith, Christophe Combescure, Christophe Baréa, Jonas Oldgren, Laurna McGovern, J J Coughlan, Rory Durand, Stephan Windecker, Andrè Frenk, Bernadette Coles, Arjola Bano, Juri Künzler, Faina Wehrli, Lum Kastrati, Markus Laimer, Elisabetta Biasin, Erik Kamenjašević, J. Gary Meszaros, Isabelle Huys, Pascal Borry, Ursula Rochau, Tanja Planinschitz, Uwe Siebert, David Epstein, John Eric Chaplin, Ola Rolfson, Enrico G. Caiani, Yijun Ren, Donal B O’Connor, Gearóid McGauran, G. A. O’Connor, Niall MacAleenan, Sanjeev Yoganathan, Jan Szulc, Robert E. Geertsma, Jantine W.P.M. van Baal, Paola Laricchiuta, E. Carrani, Stefania Ceccarelli, Enrico Ciminello, Sabine Ettinger, Juan Antonio Blasco‐Amaro, Agnieszka Dobrzynska, Jesús Aranda, Juan Carlos Rejón-Parrilla, Françoise Schlemmer, Sabina Hoekstra, Richard Holborow, Marianna Mastroroberto, Erman Melikyan, Alexey Shiryaev, Christoph Ziskoven (2025). Recommended methodologies for clinical investigations of high-risk medical devices—Conclusions from the European Union CORE–MD Project. , 58, DOI: https://doi.org/10.1016/j.lanepe.2025.101460.
Article2 days ago