Translational Pathways For Cardiovascular Devices

Part I: Basic Concepts In Device Development

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

II.1	Introduction (Preview Free Article & Lectures From Doctors Cribier & Leon)
	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

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

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

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
	David J. Farrar, PhD; Philip B. Adamson, MD, MSc
V.6	Reimbursement
	Robin Bostic
V.7	Future of VADs
	Francis D. Pagani, MD

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

VII.1	Advanced Cardiac Anatomy: Application in Translational Research Tailored to Current and Future Technology
	Renu Virmani, MD
VII.2	Introduction to the Cardiac Catheterization Laboratory
	Morton Kern, MD