Translational Pathway to Expedite Scientific Discovery to Patients

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

Lecture – Rachel Neubrander, PhD, FDA

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

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Translational Pathway to Expedite Scientific Discovery to Patients

Translational Pathways for Cardiovascular Devices Translational Pathway to Expedite Scientific Discovery to Patients

Robert Califf, MD

Former Commissioner of Food and Drug Administration, FDA

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