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Donation Total: $100.00

Editors: Nabil Dib, MD; Spencer King, MD; Anthony DeMaria, MD

Part I: Basic Concepts In Device Development

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I.1Introduction (Preview Free Article)
David R. Holmes, MD; Anthony DeMaria, MD; Nabil Dib, MD, MSc; Spencer King III, MD; David G. Reuter, MD, PhD
I.2Overview of Cardiovascular Translational Research (Preview Free Article & Lectures From Doctors Dib & Califf)
Nabil Dib, MD, MSc
I.3A 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.4Intellectual Property and Strategy Development
Neil K. Nydegger, Esq
I.5Business Planning, Product Development and Fundraising: The Three Amigos of Your Device Start-Up
Stanton Rowe
I.6Regulatory Requirement for Marketing Approval
Felipe Aguel; Deborah G. Castillo, PhD; Joseph Chin, MD; Bram D. Zuckerman, MD
I.7Regulatory 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.8Requirements for Reimbursement for Innovation
Joseph Chin, MD; Seth Clancy
I.9The ABCs of Reimbursement for Breakthrough Devices
Tonya Dowd, MPH; Simran Madhani
I.10Requirement for New Technology to be Included in the Guidelines: “The Ultimate Goal”
Alice Jacobs, MD
I.11Advanced Biostatistics for Translational Research
Chris Mullin; Roseann White
I.12Early Feasibility Studies
Andrew Farb, MD; David G. Reuter, MD, PhD

Part II: Translational Pathway For Transcatheter Aortic Valves

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

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

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

Part IV:Translational Pathway For Coronary Stent Development

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

Part V: Translational Pathway For Ventricular Assist Devices

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

Part VI: Translational Pathway for Catheter Ablation

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

Part VII: Supplemental Chapters

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