INTRODUCTION

Welcome from the Course Directors

3 Topics

Course Director Nabil Dib, MD

Course Director Spencer B. King, MD

Course Director Anthony N. DeMaria, MD

Course Description

8 Topics

Fulfill Unmet Educational Need (Knowledge Gap)

Translational Pathway for Trans Aortic Valve Replacement-TAVR

FlowFusion ND Infusion Catheter

U.S. Regulatory Device Evaluation

Translational Pathways for Cardiovascular Devices

Translational Pathway for Cardiovascular Therapy

Who should take this course?

Course Sessions

Translational Pathway to Expedite Scientific Discovery to Patients

Meet the Legends of Innovation

SESSION I: BASIC KNOWLEDGE FOR CV DEVICES DEVELOPMENT

Session I Introduction: Medical Device Development

Concept/Innovation

1 Topic | 1 Quiz

Lecture – Todd Brinton, MD, Edward’s Lifesciences

Translational Pathways for Cardiovascular Devices – Session 1: Concept / Innovation – Choosing an Innovative Concept – Todd Brinton Practice Quiz

Intellectual Property

1 Topic | 1 Quiz

Lecture – James Inskeep, Patent Attorney

Translational Pathways for Cardiovascular Devices – Session 1: Intellectual Property – James Inskeep Practice Quiz

Business Plan, Development, and Fundraising

1 Topic | 1 Quiz

Lecture – Stan Rowe, Edward’s Lifesciences

Translational Pathways for Cardiovascular Devices – Session 1: Business Plan, Product Development, and Fundraising – Stan Rowe Practice Quiz

Product Manufacturing

2 Topics | 2 Quizzes

Lecture – Brad Quinn, FDA

Translational Pathways for Cardiovascular Devices – Session 1: Product Manufacturing – Requirements for Medical Device Manufacturing and Iteration FDA Point of View – Brad Quinn Practice Quiz

Lecture – Richard Rapoza, PhD, Abbott Vascular

Translational Pathways for Cardiovascular Devices – Session 1: Requirements for Medical Device Manufacturing and Iteration Industry Point of View – Richard Rapoza Practice Quiz

Preclinical Evaluation

4 Topics | 4 Quizzes

Lecture – Renu Virmani, MD, CV Path Institute

Translational Pathways for Cardiovascular Devices – Session 1: Preclinical Evaluation -Advanced Cardiac Anatomy – Application in Translational Research Tailored to Current and Future Technology – Renu Virmani Practice Quiz

Lecture – Daniel Burkhoff, MD, Colombia University

Translational Pathways for Cardiovascular Devices – Session 1: Large Animal Model for Heart Failure, Valvular Disease, Coronary Artery Disease, and Device Testing – Daniel Burkhoff Practice Quiz

Lecture – Judith Davis, DVM, MS, FDA

Translational Pathways for Cardiovascular Devices – Session 1: Pre-Clinical Study Design and Endpoints for Device Evaluation FDA Point Of View – Judith Davis Practice Quiz

Lecture – Renu Virmani, MD, CV Path Institute

Translational Pathways for Cardiovascular Devices – Session 1: Pre-Clinical Study Design and Endpoints for Device Evaluation Investigator Point Of View – Renu Virmani Practice Quiz

Early Feasibility Study

2 Topics | 2 Quizzes

Lecture – Andrew Farb, MD, FDA

Translational Pathways for Cardiovascular Devices – Session 1: Early Feasibility Study – Early Feasibility Studies for Device Evaluation – Andrew Farb Practice Quiz

Lecture – David Reuter, MD, Seattle Children’s Hospital

Translational Pathways for Cardiovascular Devices – Session 1: Current Challenges and Future Direction for Human Early Feasibility Study for Device Evaluation – Industry Point of View – David Reuter Practice Quiz

Biostatistics

10 Topics | 10 Quizzes

Lecture – Chris Mullin, PhD, NAMSA

Translational Pathways for Cardiovascular Devices – Session 1: Biostatistics – Basic in Statistics – Clinical Study Design for Translational Research – Chris Mullin Practice Quiz

Lecture – Chris Mullin, PhD, NAMSA

Translational Pathways for Cardiovascular Devices – Session 1: Basic in Statistics- Basic Statistical Concepts – Chris Mullin Practice Quiz

Lecture – Chris Mullin, PhD, NAMSA

Translational Pathways for Cardiovascular Devices – Session 1: Basic in Statistics – Sample Size and Power – Chris Mullin Practice Quiz

Lecture – Chris Mullin, PhD, NAMSA

Translational Pathways for Cardiovascular Devices – Session 1: Basic in Statistics – Sensitivity and Specificity – Chris Mullin Practice Quiz

Lecture – Chris Mullin, PhD, NAMSA

Translational Pathways for Cardiovascular Devices – Session 1: Basic in Statistics – Common Study Design – Chris Mullin Practice Quiz

Lecture – Chris Mullin, PhD, NAMSA

Translational Pathways for Cardiovascular Devices – Session 1: Basic in Statistics – Phases of Translational Research – Chris Mullin Practice Quiz

Lecture – Chris Mullin, PhD, NAMSA

Translational Pathways for Cardiovascular Devices – Session 1: Statistics for Evaluation of Cardiovascular Diagnostic Devices- Chris Mullin Practice Quiz

Lecture – Roseann White, PhD, Duke Research Institute

Translational Pathways for Cardiovascular Devices – Session 1: Pre-Clinical and Clinical Trial Design and Endpoints of Fast Track to Device Approval – Roseann White Practice Quiz

Lecture – Chris Mullin, PhD, NAMSA

Translational Pathways for Cardiovascular Devices – Session 1: Advanced Statistical Methods for Translational Research- Chris Mullin Practice Quiz

Lecture – Roseann White, PhD, Duke Research Institute

Translational Pathways for Cardiovascular Devices – Session 1: Clinical Endpoints/Surrogate Endpoints – Roseann White Practice Quiz

Regulatory Approval

4 Topics | 3 Quizzes

Lecture – Bram Zuckerman, MD, FDA

Translational Pathways for Cardiovascular Devices – Session 1: Regulatory Approval – Regulatory Requirement for Marketing Approval – Bram Zuckerman Practice Quiz

FDA Perspective on Transformative Regulatory Pathways and Device Innovation

Lecture – Marco Cannella, PhD, FDA

Translational Pathways for Cardiovascular Devices – Session I: Regulatory Review of Cardiovascular Diagnostic devices – FDA Perspective – Marco Cannella Practice Quiz

Lecture – Robert Byrne, MD, Heart Centre, Germany

Translational Pathways for Cardiovascular Devices – Session 1: Regulatory Review of Cardiovascular Devices: European Regulatory Perspective – Robert Byrne Practice Quiz

Reimbursement

2 Topics | 2 Quizzes

Lecture – Joseph Chin, MD, CMS

Translational Pathways for Cardiovascular Devices – Session 1: Reimbursement – CMS Criteria for Reimbursement for Cardiovascular Innovation – Joseph Chin Practice Quiz

Lecture – Lori Ashby, CMS

Translational Pathways for Cardiovascular Devices – Session I: Reimbursement for Diagnostic Devices – Lori Ashby Practice Quiz

Practice Guideline

2 Topics | 2 Quizzes

Lecture – Alice Jacobs, MD, Boston University

Translational Pathways for Cardiovascular Devices – Session 1: Practice Guideline – Practice Guideline Requirement for New Technology – Alice Jacobs Practice Quiz

Lecture – Roxana Mehran, MD, Icahn School of Medicine, Mount Sinai

Translational Pathways for Cardiovascular Devices – Session I: Guideline Requirement for Diagnostic Devices – Roxanna Mehran Practice Quiz

Technology Adoption

2 Topics | 2 Quizzes

Lecture – Ian Meredith, MD, Boston Scientific

Translational Pathways for Cardiovascular Devices – Session 1: Technology Adoption – Adoption of Technology – Ian Meredith Practice Quiz

Lecture – Salim Yusuf, D. Phil, World Federation of Cardiology

Translational Pathways for Cardiovascular Devices – Session 1: Global Heart Health, Implications for Translational Research – Salim Yusuf Practice Quiz

Conflict of Interest

1 Topic | 1 Quiz

Lecture – Anthony DeMaria, MD, UCSD

Translational Pathways for Cardiovascular Devices – Session I: Conflict of Interest – Anthony DeMaria Practice Quiz

Patients

1 Topic | 1 Quiz

Lecture – Mark Mercola, PhD, Stanford Cardiovascular Institute

Translational Pathways for Cardiovascular Devices – Session 1: Patients Voice – Mark Mercola Practice Quiz

Panel Discussions

5 Topics

2019 Diagnostic Devices Development

2019 Device Development: Essential Concepts

2018 Requirements for CV Devices Approval

2017 Clinical Endpoints & Biostatistics

2016 Preclinical, Early Feasibility, and Safety Study for Device Development

Session I: Basic Knowledge for CV Devices Development Final Quiz

1 Quiz

Translational Pathways for Cardiovascular Devices – Session I: Basic Knowledge for CV Devices Development Final Quiz

Basic Knowledge for Medical Device Development – End

SESSION II: TRANSLATIONAL PATHWAY FOR TRANSCATHETER AORTIC VALVE

Session II: Translational Pathway for Transcatheter Aortic Valve

The Clinical Need for Innovative Treatment for Aortic Valve Disease

The Methods for Transcatheter Aortic Valve Development

The Endpoints for Transcatheter Aortic Valve Development

Current Challenges and Future Direction for Aortic Valve Development and Iteration – FDA Point of View

Current Challenges and Future Direction for Aortic Valve Development and Iteration – Industry Point of View

The TAVR Development from Concept to First in Man

The TAVR Development from First in Man to Phase 3 and Beyond

Panel Discussions

2 Topics

2017 Valve Disease/TAVR

2016 Aortic Valve Development

Session II: Translational Pathway For Transcatheter Aortic Valve Final Quiz

1 Quiz

Translational Pathways for Cardiovascular Devices – Session II: Translational Pathway For Transcatheter Aortic Valve Final Quiz

Session II: Translational Pathway for Transcatheter Aortic Valve – End

SESSION III: TRANSLATIONAL PATHWAY FOR TRANSCATHETER MITRAL/TRICUSPID VALVE DEVICES

Session III: Translational Pathway for Transcatheter Mitral/Tricuspid Valve Devices

1 Topic

Session III Topics

The Clinical Need for Innovative Treatment for Mitral/Tricuspid Valve Disease

The Methods for Translational Mitral/Tricuspid Valve Device Development

The Endpoints for Transcatheter Mitral/Tricuspid Valve Device Development

Current Challenges and Future Direction for Mitral/Tricuspid Valve Device Development and Iteration – FDA Point of View

Current Challenges and Future Direction for Mitral/Tricuspid Valve Device Development and Iteration – Industry Point of View

Unmet Clinical Needs for Tricuspid Valve Interventions

Current Imaging Limitations for the Advancement of Tricuspid Valve Interventions

Tricuspid Valve Interventions: Challenges from the Regulatory Perspective

Panel Discussions

3 Topics

2019 Structural Heart Intervention Imaging

2017 MV/TV Transcatheter Repair/Replacement

2016 MV/TV Development

Session III: Translational Pathway For Transcatheter Mitral/Tricuspid Valve Devices Final Quiz

1 Quiz

Translational Pathways for Cardiovascular Devices – Session III: Translational Pathway For Transcatheter Mitral/Tricuspid Valve Devices Final Quiz

Session III: Translational Pathway for Transcatheter Mitral/Tricuspid Valve Devices – End

SESSION IV: TRANSLATIONAL PATHWAY FOR CORONARY STENT

Session IV: Translational Pathway for Coronary Stent

1 Topic

Session IV Topics

The Clinical Need for Innovative Coronary Stent

The Methods for Coronary Stent Development

The Endpoints for Coronary Stent Development

Current Challenges and Future Direction for Coronary Stent Development and Iteration – FDA Point of View

Current Challenges and Future Direction for Coronary Stent Development and Iteration – Industry Point of View

Unmet Clinical Needs, Value Added and Future Direction in CT Lesion Assessment

Unmet Clinical Needs, Current and Future Direction in Intracoronary Physiology and Imaging Assessment

Advances in the Assessment of High-Risk Coronary Lesions – Non-Clinical Evaluation

Advances in the Assessment of High-Risk Coronary Lesions – FDA Perspective

Revascularization and Devices for Complex Coronary Lesions – Calcified, Total Occlusion – Unmet Clinical Needs / Future Directions

Revascularization and Devices for Complex Coronary Lesions – Calcified, Total Occlusion – Non-Clinical Evaluation

Revascularization and Devices for Complex Coronary Lesions – Calcified, Total Occlusion – FDA Perspectives

Panel Discussions

4 Topics

2019 Devices for Complex Coronary Lesions

2019 Advances in the Assessment of High Risk Coronary Lesions

2017 CAD/Coronary Stent

2016 Coronary Stent Development

Session IV: Translational Pathway for Coronary Stent Development Final Quiz

1 Quiz

Translational Pathways for Cardiovascular Devices – Session IV: Translational Pathway for Coronary Stent Development Final Quiz

Session IV: Translational Pathway for Coronary Stent – End

SESSION V: TRANSLATIONAL PATHWAY FOR CATHETER ABLATION

Session V: Translational Pathway for Catheter Ablation

1 Topic

Session V Topics

The Clinical Need for the Treatment of Arrhythmia Innovative Catheter Ablation

Methods for Catheter Ablation Development

The Endpoints for Catheter Ablation Development

Current Challenges and Future Direction for Catheter Ablation Development and Iteration – FDA Point of View

Current Challenges and Future Direction for Catheter Ablation Development and Iteration – Industry Point of View

Panel Discussions

2 Topics

2017 Arrhythmia/Catheter Ablation

2016 Catheter Ablation Development

Session V: Translational Pathway for Catheter Ablation Final Quiz

1 Quiz

Translational Pathways for Cardiovascular Devices – Session V: Translational Pathway for Catheter Ablation Final Quiz

Session V: Translational Pathway for Catheter Ablation – End

SESSION VI: TRANSLATIONAL PATHWAY FOR VENTRICULAR ASSIST DEVICES

Session VI: Translational Pathway for Ventricular Assist Devices

1 Topic

Session VI Topics

Ventricular Assist Devices, The Windy Road to Recovery

The Methods for Left Ventricular Assist Devices Development

The Endpoints for Left Ventricular Assist Device Evaluation

Panel Discussions

2 Topics

2018 Translational Pathway for LV Assist Devices

2017 CHF/Ventricular Assist Devices

Session VI: Translational Pathway for Ventricular Assist Devices Final Quiz

1 Quiz

Translational Pathways for Cardiovascular Devices – Session VI: Translational Pathway for Ventricular Assist Devices Final Quiz

Session VI: Translational Pathway for Ventricular Assist Devices – End

SESSION VII: TRANSLATIONAL PATHWAY FOR INTERVENTIONAL DEVICES FOR HEART FAILURE

Session VII: Translational Pathway for Interventional Devices for Heart Failure

1 Topic

Session VII Topics

Overview of Interventional Devices for Heart Failure

Current Landscape and Future Direction – Percutaneous Ventricular Assist Devices

Current Landscape and Future Direction of Neuromodulation Heart Failure Therapies

Current Landscape and Future Direction – Intracardiac Shunts and Ventricular Remodeling Therapies

Interventional Devices for Heart Failure – Non-Clinical Evaluation

Interventional Devices for Heart Failure – FDA Perspective

Panel Discussion

1 Topic

TCT 2019 Heart Failure

Session VII: Translational Pathway for Interventional Devices for Heart Failure Final Quiz

1 Quiz

Translational Pathways for Cardiovascular Devices – Session VII: Translational Pathway for Interventional Devices for Heart Failure Final Quiz

Session VII: Translational Pathway for Interventional Devices for Heart Failure – End

SESSION VIII: TRANSLATIONAL PATHWAY FOR LEFT ATRIAL APPENDAGE CLOSURE DEVICES

Session VIII: Translational Pathway for Left Atrial Appendage Closure Devices

1 Topic

Session VIII Topics

Unmet Clinical Needs/Current and Future Direction

Current and Future Left Atrial Appendage Imaging Modalities to Optimize LAA Closure

Left Atrial Appendage Closure Devices – FDA Perspective

Panel Discussion

1 Topic

TCT 2019 Left Atrial Appendage Closure

Session VIII: Translational Pathway for Left Atrial Appendage Closure Devices Final Quiz

1 Quiz

Translational Pathways for Cardiovascular Devices – Session VIII: Translational Pathway for Left Atrial Appendage Closure Devices Final Quiz

Session VIII: Translational Pathway for Left Atrial Appendage Closure Devices – End

Supplemental Session

Lectures in Cardiovascular Medicine

2 Topics

Introduction to the Cardiac Cath Lab

Cardiac Imaging: The Right Test for the Right Patient

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The TAVR Development from Concept to First in Man

Translational Pathways for Cardiovascular Devices The TAVR Development from Concept to First in Man

Alain Cribier, MD

Professor of Medicine and Director of Cardiology at the

University of Rouen, Charles Nicolle Hospital, France

Learning Objectives

Recognize the challenges to design iteration
Understand the tailored trial design
Learn the regulatory pathway for approval for device iteration
Learn the regulatory pathway for approval for indication expansion
Learn the use of real world data

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