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 Topics

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 Medical Devices: Concept / Innovation – Choosing an Innovative Concept – Todd Brinton Practice Quiz

Intellectual Property

1 Topic | 1 Quiz

Lecture – James Inskeep, Patent Attorney

Translational Pathways for Medical Devices: Intellectual Property – James Inskeep Practice Quiz

Business Plan, Development, and Fundraising

1 Topic | 1 Quiz

Lecture – Stan Rowe, Edward’s Lifesciences

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

Product Manufacturing

2 Topics | 2 Quizzes

Lecture – Brad Quinn, FDA

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

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

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

Lecture – Chris Mullin, PhD, NAMSA

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

Lecture – Chris Mullin, PhD, NAMSA

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

Lecture – Chris Mullin, PhD, NAMSA

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

Lecture – Chris Mullin, PhD, NAMSA

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

Lecture – Chris Mullin, PhD, NAMSA

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

Lecture – Chris Mullin, PhD, NAMSA

Translational Pathways for Medical Devices: Statistics for Evaluation of Cardiovascular Diagnostic Devices- Chris Mullin Practice Quiz

Lecture – Roseann White, PhD, Duke Research Institute

Translational Pathways for Medical Devices: 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 Medical Devices: Advanced Statistical Methods for Translational Research- Chris Mullin Practice Quiz

Lecture – Roseann White, PhD, Duke Research Institute

Translational Pathways for Medical Devices: Clinical Endpoints/Surrogate Endpoints – Roseann White Practice Quiz

Regulatory Approval

4 Topics | 3 Quizzes

Lecture – Bram Zuckerman, MD, FDA

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

Lecture – Robert Byrne, MD, Heart Centre, Germany

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

Lecture – Lori Ashby, CMS

Translational Pathways for Medical Devices: Reimbursement for Diagnostic Devices – Lori Ashby Practice Quiz

Practice Guideline

2 Topics | 2 Quizzes

Lecture – Alice Jacobs, MD, Boston University

Translational Pathways for Medical Devices: 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 Medical Devices: Guideline Requirement for Diagnostic Devices – Roxanna Mehran Practice Quiz

Technology Adoption

2 Topics | 2 Quizzes

Lecture – Ian Meredith, MD, Boston Scientific

Translational Pathways for Medical Devices: Technology Adoption – Adoption of Technology – Ian Meredith Practice Quiz

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

Translational Pathways for Medical Devices: 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 Medical Devices: Conflict of Interest – Anthony DeMaria Practice Quiz

Patients

1 Topic | 1 Quiz

Lecture – Mark Mercola, PhD, Stanford Cardiovascular Institute

Translational Pathways for Medical Devices: 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

Session III

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

Session IV: Translational Pathway for Coronary Stent

SESSION IV: TRANSLATIONAL PATHWAY FOR CORONARY STENT

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

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

Session V: Translational Pathway for Catheter Ablation Final Quiz

Session V: Translational Pathway for Catheter Ablation – End

Panel Discussions

HOPPER

Panel Discussions

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Welcome from the Course Directors

Translational Pathways for Cardiovascular Devicesv2 Welcome from the Course Directors

Translational Pathways for Cardiovascular Devices

INTRODUCTION

Session Content

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Course Director Nabil Dib, MD

Course Director Spencer B. King, MD

Course Director Anthony N. DeMaria, MD

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