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Part I: Basic Concepts In Device Development

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I.1 Introduction
Anthony DeMaria, MD; David R. Holmes, MD; Spencer King III, MD; David G. Reuter, MD, PhD
I.2 Overview of Cardiovascular Translational Research
Nabil Dib, MD, MSc
I.3 A Needs-Based Approach to Health Technology Innovation: The Stanford Biodesign Process Concept Development for Unmet Clinical Needs
Todd J. Brinton, MD; Uday N. Kumar, MD; Jonathan G. Schwartz, MD; Paul G. Yock, MD
I.4 Intellectual Property and Strategy Development
Neil K. Nydegger, Esq
I.5 Regulatory Requirement for Marketing Approval
Felipe Aguel; Deborah G. Castillo, PhD; Joseph Chin, MD; Bram D. Zuckerman, MD
I.6 Regulatory Assessment of Medical Devices in the European Union
Alan G. Fraser, MD; Robert A. Byrne, PhD; Tom Melvin, MD; Niall MacAleenan, MD; Olga Tkachenko, PhD; Paul Piscoi, MD
I.7 Requirements for Reimbursement for Innovation
Joseph Chin, MD; Seth Clancy
I.8 Requirement for New Technology to be Included in the Guidelines: “The Ultimate Goal”
Alice Jacobs, MD
I.9 Advanced Biostatistics for Translational Research
Chris Mullin; Roseann White
I.10 Early Feasibility Studies
Andrew Farb, MD; David G. Reuter, MD, PhD

Part II: Translational Pathway For Transcatheter Aortic Valves

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II.1 Introduction
Stanton Rowe
II.2 Unmet Clinical Needs
Martin B. Leon, MD
II.3 Preclinical Evaluation for TAVR
Sarah Ahlberg, Carol E. Eberhardt, Russell Hodge, Timothy Kelley, Jeffrey Kepner, Hatem Tadros
II.4 Clinical Evaluations – Methods
Nicole Ibrahim, PhD
II.5 Clinical Evaluations – Endpoints
Ori Ben-Yehuda, MD
II.6 Reimbursement
Seth Clancy
II.7 Future of TAVR Devices
Stanton Rowe

Part III: Translational Pathway For Transcatheter Mitral And Tricuspid Valve Development

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III.1 Introduction
Blasé Carabello, MD
III.2 Unmet Clinical Needs
Blasé Carabello, MD
III.3 Preclinical Evaluation of Percutaneous Mitral/Tricuspid Valve Repair/Replacement
Patrick Verta, MS, DVM, MD
III.4 Clinical Evaluations – Methods
John Laschinger, MD
III.5 Clinical Evaluations – Endpoints
Blasé Carabello, MD; Anthony DeMaria, MD; David Holmes, MD; Spencer King III, MD; John Laschinger, MD; Patrick Verta, MS, DVM, MD
III.6 Reimbursement
Christopher J. Panarites, PhD; Elizabeth Thoma, MBA
III.7 Future of Mitral and Tricuspid Devices
Paul Grayburn, MD

Part IV:Translation Pathway For Coronary Stent Development

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IV.1 Introduction
Chuck Simonton, MD
IV.2 Unmet Clinical Needs
Stephen Ellis, MD; Chuck Simonton MD
IV.3 Preclinical Evaluation of Coronary Stents
Laura E. Leigh Perkins, DVM, PhD, DACVP
IV.4 Clinical Evaluations – Methods
Priya Jagasia, MD; Chuck Simonton, MD
IV.5 Clinical Evaluations – Endpoints
Donald E. Cutlip, MD
IV.6 Reimbursement
Chuck Simonton, MD
IV.7 Future of Coronary Stents
Mitchell W. Krucoff, MD

Part V: Translational Pathway For Ventricular Assist Devices

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V.1 Introduction
Francis D. Pagani, MD
V.2 Unmet Clinical Needs
Francis D. Pagani, MD
V.3 Preclinical Evaluation of VADs
Kevin Bourque; Changfu Wu, PhD
V.4 Clinical Evaluations – Methods
Francis D. Pagani, MD; Changfu Wu, PhD
V.5 Clinical Evaluations – Endpoints
Philip B. Adamson, MD, MSc; David J. Farrar, PhD
V.6 Reimbursement
Robin Bostic
V.7 Future of VADs
Francis D. Pagani, MD

Part VI: Translational Pathway for Catheter Ablation

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VI.1 Introduction
Gregory K. Feld, MD
VI.2 Unmet Clinical Needs
Gregory K. Feld, MD
VI.3 Preclinical Evaluation for Catheter Ablation
Tim Laske, PhD
VI.4 Clinical Evaluations
Marco Cannella, PhD
VI.5 Reimbursement
Tonya Dowd, MPH
VI.6 Future of Catheter Ablation
Gregory K. Feld, MD