/  Part II


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
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
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


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