Part II: Translational Pathway for Devices
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II.1 | Regulatory Pathway for 510k, IDE, and PMA |
Deborah G Castillo PhD, Bram Zuckerman MD and Felipe Aguel PhD | |
II.2 | EU Regulatory Frameworks for Medicines and Medical Devices for Cardiovascular Disease |
Peter Feldschreiber LLB and Alasdair Breckenridge MD | |
II.3 | Product Development of Devices |
Robert E Kohler MS | |
II.4 | Large Animal Models for Cardiovascular Device Development |
Yanping Cheng MD, Daniel Burkhoff MD PhD and Juan Granada MD |
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II.5 | Translational Platform for Aortic Valve Replacement |
Alain Cribier MD | |
II.6 | Translational Pathway for Tissue Engineered Aortic Valves |
Jerome Sohier PhD, Adrian H Chester BSC PhD and Sir Magdi H Yacoub MD |
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II.7 | Translational Platform for Mitral Valve Repair and Replacement |
David G Reuter MD PhD and Patrick M Sullivan MD | |
II.8 | Electrophysiology: Translational Research Platforms |
Fu Siong Ng PhD, Michael T Debney and Nicholas S Peters MD | |
II.9 | The Translational Pathway for Mechanical Circulatory Support |
Toshinobu Kazui MD PhD, Tia Pilikian MS, Destiny Lagrand BA, Richard G Smith MSEE CCE, Sir Magdi H Yacoub MD and Zain Khalpey MD PhD |