Lecture &#8211; Robert Califf, MD, FDA

Lecture – Robert Califf, MD, FDA

Meet the Legends of Innovation

2 Topics

Lecture – Legends of Innovation

SESSION I: BASIC KNOWLEDGE FOR CV DEVICES DEVELOPMENT

Session I

Medical Device Development

Concept/Innovation

3 Topics | 1 Quiz

Choosing an Innovative Concept

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

3 Topics | 1 Quiz

Intellectual Property

Lecture – James Inskeep, Patent Attorney

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

Business Plan, Development, and Fundraising

3 Topics | 1 Quiz

Business Plan, Product Development, and Fundraising

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

7 Topics | 2 Quizzes

Requirements for Medical Device Manufacturing and Iteration FDA Point of View

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

Requirements for Medical Device Manufacturing and Iteration Industry Point of View

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

19 Topics | 5 Quizzes

Advanced Cardiac Anatomy – Application in Translational Research Tailored to Current and Future Technology

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

Introduction to the Cardiac Cath Lab

Lecture – Morton Kern, MD, VA Long Beach

Translational Pathways for Cardiovascular Devices – Session I: Preclinical Evaluation: Introduction to the Cardiac Cath Lab – Morton Kern Question Practice Quiz

Large Animal Model for Heart Failure, Valvular Disease, Coronary Artery Disease, and Device Testing

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

Pre-Clinical Study Design and Endpoints for Device Evaluation FDA Point Of View

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

Pre-Clinical Study Design and Endpoints for Device Evaluation Investigator Point Of View

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

7 Topics | 2 Quizzes

Early Feasibility Studies for Device Evaluation

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

Current Challenges and Future Direction for Human Early Feasibility Study for Device Evaluation – Industry Point of View

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

33 Topics | 10 Quizzes

Basic in Statistics

Clinical Study Design for Translational Research – Learning Objectives

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

Basic Statistical Concepts – Learning Objectives

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

Sample Size and Power – Learning Objectives

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

Sensitivity and Specificity – Learning Objectives

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

Common Study Design – Learning Objectives

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

Phases of Translational Research- Learning Objectives

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

Statistics for Evaluation of Cardiovascular Diagnostic Devices – Learning Objectives

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

Pre-Clinical and Clinical Trial Design and Endpoints of Fast Track to Device Approval

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

Advanced Statistical Methods for Translational Research

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

Clinical Endpoints/Surrogate Endpoints

Lecture – Roseann White, PhD, Duke Research Institute

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

Regulatory Approval

11 Topics | 3 Quizzes

Regulatory Requirement for Marketing Approval

Lecture – Bram Zuckerman, MD, FDA

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

Regulatory Review of Cardiovascular Diagnostic Devices FDA Perspective

Lecture – Marco Cannella, PhD, FDA

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

Regulatory Review of Cardiovascular Devices: European Regulatory Perspective

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

7 Topics | 2 Quizzes

CMS Criteria for Reimbursement for Cardiovascular Innovation

Lecture – Joseph Chin, MD, CMS

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

Reimbursement for Diagnostic Devices

Lecture – Lori Ashby, CMS

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

Practice Guideline

7 Topics | 2 Quizzes

Practice Guideline Requirement for New Technology

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

Guideline Requirements for Diagnostic Devices

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

7 Topics | 2 Quizzes

Adoption of Technology

Lecture – Ian Meredith, MD, Boston Scientific

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

Global Heart Health, Implications for Translational Research

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

3 Topics | 1 Quiz

Conflict of Interest and Product Development

Lecture – Anthony DeMaria, MD, UCSD

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

Patients

3 Topics | 1 Quiz

The Patients Voice

Lecture – Mark Mercola, PhD, Stanford Cardiovascular Institute

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

2019 Diagnostic Devices Development

5 Topics

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

Session II: Translational Pathway for Transcatheter Aortic Valve

1 Topic

Session II Topics

The Clinical Need for Innovative Treatment for Aortic Valve Disease

2 Topics

Lecture – Martin Leon, MD, Columbia University

The Methods for Transcatheter Aortic Valve Development

2 Topics

Lecture – Stan Rowe, Edwards’s Lifesciences

The Endpoints for Transcatheter Aortic Valve Development

2 Topics

Lecture – Ori Ben-Yehuda, MD, Cardiovascular Research Foundation

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

2 Topics

Lecture – Nicole Ibrahim, PhD, FDA

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

2 Topics

Lecture – Stan Rowe, Edward’s Lifesciences

The TAVR Development from Concept to First in Man

2 Topics

Lecture – Alain Cribier, MD, University of Rouen, France

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

2 Topics

Lecture – Martin Leon, MD, Columbia University

2016 Aortic Valve Development

2 Topics

2017 Valve Disease/TAVR

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

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

2 Topics

Lecture – Michael Mack, MD, Baylor Scott & White Health

The Methods for Translational Mitral/Tricuspid Valve Device Development

2 Topics

Lecture – Michael Mack, MD, Baylor Scott & White Health

The Endpoints for Transcatheter Mitral/Tricuspid Valve Device Development

2 Topics

Lecture – Blasé Carabello, MD, East Carolina University

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

2 Topics

Lecture – John Laschinger, MD, FDA

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

2 Topics

Lecture – Patricia Todd, Edward’s Lifesciences

Unmet Clinical Needs for Tricuspid Valve Interventions

2 Topics

Lecture – Carlos Sanchez, MD

Current Imaging Limitations for the Advancement of Tricuspid Valve Interventions

2 Topics

Lecture – Rebecca Hahn, MD, Columbia University Medical Center

Tricuspid Valve Interventions: Challenges from the Regulatory Perspective

2 Topics

Lecture – Changfu Wu, PhD, FDA

2019 Structural Heart Intervention Imaging

3 Topics

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

Session IV: Translational Pathway for Coronary Stent

1 Topic

Session IV Topics

The Clinical Need for Innovative Coronary Stent

2 Topics

Lecture – Gregg Stone, MD, Columbia University

The Methods for Coronary Stent Development

2 Topics

Lecture – Charles Simonton, MD, Abbott Vascular

The Endpoints for Coronary Stent Development

2 Topics

Lecture – Donald Cutlip, MD, Beth Israel-Deaconess

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

2 Topics

Lecture – Michael John, MPH, FDA

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

2 Topics

Lecture – Charles Simonton, MD, Abbott Vascular

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

2 Topics

Lecture – James Min, MD, Weill Cornell Medicine

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

2 Topics

Lecture – Morton Kern, MD

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

2 Topics

Lecture – Robert Safian, MD

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

2 Topics

Lecture – Shawn Forrest, FDA

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

2 Topics

Lecture – Ajay Kirtane, MD, Columbia University Medical Center

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

2 Topics

Lecture – Kevin Croce, MD, PhD, Harvard Medical School

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

2 Topics

Lecture – Lydia Glaw, PhD, FDA

2019 Devices for Complex Coronary Lesions

4 Topics

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

Session V: Translational Pathway for Catheter Ablation

1 Topic

Session V Topics

The Clinical Need for the Treatment of Arrhythmia Innovative Catheter Ablation

2 Topics

Lecture – Douglas Packer, MD, Mayo Clinic

Methods for Catheter Ablation Development

2 Topics

Lecture – Douglas Packer, MD, Mayo Clinic

The Endpoints for Catheter Ablation Development

2 Topics

Lecture – Marco Cannella, PhD, FDA

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

2 Topics

Lecture – Mark Fellman, MS, FDA

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

2 Topics

Lecture – Uri Yaron, PhD, Johnson & Johnson

2017 Arrhythmia/Catheter Ablation

2 Topics

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

Session VI: Translational Pathway for Ventricular Assist Devices

1 Topic

Session VI Topics

Ventricular Assist Devices, The Windy Road to Recovery

2 Topics

Lecture – Sr. Magdi Yacoub, MD, Imperial College, London

The Methods for Left Ventricular Assist Devices Development

2 Topics

Lecture – Francis Pagani, MD, University of Michigan

The Endpoints for Left Ventricular Assist Device Evaluation

2 Topics

Lecture – Keith Aaronson, MD, University of Michigan

2018 Translational Pathway for LV Assist Devices

2 Topics

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

Session VII: Translational Pathway for Interventional Devices for Heart Failure

1 Topic

Session VII Topics

Overview of Interventional Devices for Heart Failure

2 Topics

Lecture – William Abraham, MD, Ohio State University

Current Landscape and Future Direction – Percutaneous Ventricular Assist Devices

2 Topics

Lecture – William O’Neill, MD

Current Landscape and Future Direction of Neuromodulation Heart Failure Therapies

2 Topics

Lecture – Horst Sievert, MD

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

2 Topics

Lecture – Gregg Stone, MD, Columbia University

Interventional Devices for Heart Failure – Non-Clinical Evaluation

2 Topics

Lecture – Navin Kapur, MD, Tufts Medical Center

Interventional Devices for Heart Failure – FDA Perspective

2 Topics

Lecture – Ileana Piña, MD, FDA

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

Session VIII: Translational Pathway for Left Atrial Appendage Closure Devices

1 Topic

Session VIII Topics

Unmet Clinical Needs/Current and Future Direction

2 Topics

Lecture – Brian Whisenant, MD, University of Utah

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

2 Topics

Lecture – Dee Dee Wang, MD, Henry Ford Hospital

Left Atrial Appendage Closure Devices – FDA Perspective

2 Topics