Translational Pathways for Cardiovascular Devices

INTRODUCTION
Meet The Course Directors
3 Topics
Course Director Spencer B. King, MD
Course Director Anthony N. DeMaria, MD
Course Director Nabil Dib, MD, MSC, FACC
Welcome and Introduction
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
ISCTR Mission
2 Topics
Learning Objectives
Lecture – Nabil Dib, MD, Msc, President of ISCTR
Translational Pathway to Expedite Scientific Discovery to Patients
2 Topics
Learning Objectives
Lecture – Robert Califf, MD, FDA
Meet the Legends of Innovation
2 Topics
Learning Objectives
Lecture – Legends of Innovation
SESSION I: BASIC KNOWLEDGE FOR CV DEVICES DEVELOPMENT
Session I
Session I: Basic Knowledge for CV Devices Development
Concept/Innovation
 3 Topics | 1 Quiz
Choosing an Innovative Concept
Learning Objectives
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
Learning Objectives
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
Learning Objectives
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
 6 Topics | 2 Quizzes
Requirements for Medical Device Manufacturing and Iteration FDA Point of View
Learning Objectives
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
Learning Objectives
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
 15 Topics | 5 Quizzes
Advanced Cardiac Anatomy – Application in Translational Research Tailored to Current and Future Technology
Learning Objectives
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
Learning Objectives
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
Learning Objectives
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
Learning Objectives
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
Learning Objectives
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
 6 Topics | 2 Quizzes
Early Feasibility Studies for Device Evaluation
Learning Objectives
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
Learning Objectives
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
 24 Topics | 10 Quizzes
Basic in Statistics
Clinical Study Design for Translational Research – Learning Objectives
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
Basic Statistical Concepts – Learning Objectives
Lecture – Chris Mullin, PhD, NAMSA
Translational Pathways for Cardiovascular Devices - Session 1: Basic in Statistics- Basic Statistical Concepts – Chris Mullin Practice Quiz
Sample Size and Power – Learning Objectives
Lecture – Chris Mullin, PhD, NAMSA
Translational Pathways for Cardiovascular Devices – Session 1: Basic in Statistics - Sample Size and Power – Chris Mullin Practice Quiz
Sensitivity and Specificity – Learning Objectives
Lecture – Chris Mullin, PhD, NAMSA
Translational Pathways for Cardiovascular Devices – Session 1: Basic in Statistics - Sensitivity and Specificity – Chris Mullin Practice Quiz
Common Study Design – Learning Objectives
Lecture – Chris Mullin, PhD, NAMSA
Translational Pathways for Cardiovascular Devices – Session 1: Basic in Statistics - Common Study Design – Chris Mullin Practice Quiz
Phases of Translational Research- Learning Objectives
Lecture – Chris Mullin, PhD, NAMSA
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
Lecture – Chris Mullin, PhD, NAMSA
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
Learning Objectives
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
Learning Objectives
Lecture – Chris Mullin, PhD, NAMSA
Translational Pathways for Cardiovascular Devices – Session 1: Advanced Statistical Methods for Translational Research- Chris Mullin Practice Quiz
Clinical Endpoints/Surrogate Endpoints
Learning Objectives
Lecture – Roseann White, PhD, Duke Research Institute
Translational Pathways for Cardiovascular Devices – Session 1: Clinical Endpoints/Surrogate Endpoints – Roseann White Practice Quiz
Regulatory Approval
9 Topics | 3 Quizzes
Regulatory Requirement for Marketing Approval
Learning Objectives
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
Learning Objectives
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
Learning Objectives
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
 6 Topics | 2 Quizzes
CMS Criteria for Reimbursement for Cardiovascular Innovation
Learning Objectives
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
Learning Objectives
Lecture – Lori Ashby, CMS
Translational Pathways for Cardiovascular Devices – Session I: Reimbursement for Diagnostic Devices - Lori Ashby Practice Quiz
Practice Guideline
 6 Topics | 2 Quizzes
Practice Guideline Requirement for New Technology
Learning Objectives
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
Learning Objectives
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
 6 Topics | 2 Quizzes
Adoption of Technology
Learning Objectives
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
Learning Objectives
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
Learning Objectives
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
Learning Objectives
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
Session I: Basic Knowledge for CV Devices 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
Learning Objectives
Lecture – Martin Leon, MD, Columbia University
The Methods for Transcatheter Aortic Valve Development
 2 Topics
Learning Objectives
Lecture – Stan Rowe, Edwards’s Lifesciences
The Endpoints for Transcatheter Aortic Valve Development
 2 Topics
Learning Objectives
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
Learning Objectives
Lecture – Nicole Ibrahim, PhD, FDA
Current Challenges and Future Direction for Aortic Valve Development and Iteration - Industry Point of View
 2 Topics
Learning Objectives
Lecture – Stan Rowe, Edward’s Lifesciences
The TAVR Development from Concept to First in Man
2 Topics
Learning Objectives
Lecture – Alain Cribier, MD, University of Rouen, France
The TAVR Development from First in Man to Phase 3 and Beyond
2 Topics
Learning Objectives
Lecture – Martin Leon, MD, Columbia University
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
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
Learning Objectives
Lecture – Michael Mack, MD, Baylor Scott & White Health
The Methods for Translational Mitral/Tricuspid Valve Device Development
 2 Topics
Learning Objectives
Lecture – Michael Mack, MD, Baylor Scott & White Health
The Endpoints for Transcatheter Mitral/Tricuspid Valve Device Development
 2 Topics
Learning Objectives
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
Learning Objectives
Lecture – John Laschinger, MD, FDA
Current Challenges and Future Direction for Mitral/Tricuspid Valve Device Development and Iteration - Industry Point of View
 2 Topics
Learning Objectives
Lecture – Patricia Todd, Edward’s Lifesciences
Unmet Clinical Needs for Tricuspid Valve Interventions
 2 Topics
Learning Objectives
Lecture – Carlos Sanchez, MD
Current Imaging Limitations for the Advancement of Tricuspid Valve Interventions
 2 Topics
Learning Objectives
Lecture – Rebecca Hahn, MD, Columbia University Medical Center
Tricuspid Valve Interventions: Challenges from the Regulatory Perspective
 2 Topics
Learning Objectives
Lecture – Changfu Wu, PhD, FDA
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
Session IV: Translational Pathway for Coronary Stent
 1 Topic
Session IV Topics
The Clinical Need for Innovative Coronary Stent
 2 Topics
Learning Objectives
Lecture – Gregg Stone, MD, Columbia University
The Methods for Coronary Stent Development
 2 Topics
Learning Objectives
Lecture – Charles Simonton, MD, Abbott Vascular
The Endpoints for Coronary Stent Development
 2 Topics
Learning Objectives
Lecture – Donald Cutlip, MD, Beth Israel-Deaconess
Current Challenges and Future Direction for Coronary Stent Development and Iteration - FDA Point of View
 2 Topics
Learning Objectives
Lecture – Michael John, MPH, FDA
Current Challenges and Future Direction for Coronary Stent Development and Iteration - Industry Point of View
 2 Topics
Learning Objectives
Lecture – Charles Simonton, MD, Abbott Vascular
Unmet Clinical Needs, Value Added and Future Direction in CT Lesion Assessment
 2 Topics
Learning Objectives
Lecture – James Min, MD, Weill Cornell Medicine
Unmet Clinical Needs, Current and Future Direction in Intracoronary Physiology and Imaging Assessment
 2 Topics
Learning Objectives
Lecture – Morton Kern, MD
Advances in the Assessment of High-Risk Coronary Lesions - Non-Clinical Evaluation
 2 Topics
Learning Objectives
Lecture – Robert Safian, MD
Advances in the Assessment of High-Risk Coronary Lesions - FDA Perspectives
 2 Topics
Learning Objectives
Lecture – Shawn Forrest, FDA
Revascularization and Devices for Complex Coronary Lesions - Calcified, Total Occlusion - Unmet Clinical Needs – Current and Future Direction
 2 Topics
Learning Objectives
Lecture – Ajay Kirtane, MD, Columbia University Medical Center
Revascularization and Devices for Complex Coronary Lesions - Calcified, Total Occlusion - Non-Clinical Evaluation
 2 Topics
Learning Objectives
Lecture – Kevin Croce, MD, PhD, Harvard Medical School
Revascularization and Devices for Complex Coronary Lesions - Calcified, Total Occlusion - FDA Perspectives
 2 Topics
Learning Objectives
Lecture – Lydia Glaw, PhD, FDA
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
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
Learning Objectives
Lecture – Douglas Packer, MD, Mayo Clinic
Methods for Catheter Ablation Development
 2 Topics
Learning Objectives
Lecture – Douglas Packer, MD, Mayo Clinic
The Endpoints for Catheter Ablation Development
 2 Topics
Learning Objectives
Lecture – Marco Cannella, PhD, FDA
Current Challenges and Future Direction for Catheter Ablation Development and Iteration - FDA Point of View  
 2 Topics
Learning Objectives
Lecture – Mark Fellman, MS, FDA
Current Challenges and Future Direction for Catheter Ablation Development and Iteration - Industry Point of View  
 2 Topics
Learning Objectives
Lecture – Uri Yaron, PhD, Johnson & Johnson
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
Session VI: Translational Pathway for Ventricular Assist Devices
 1 Topic
Session VI Topics
Ventricular Assist Devices, The Windy Road to Recovery
 2 Topics
Learning Objectives
Lecture – Sr. Magdi Yacoub, MD, Imperial College, London
The Methods for Left Ventricular Assist Devices Development
 2 Topics
Learning Objectives
Lecture – Francis Pagani, MD, University of Michigan
The Endpoints for Left Ventricular Assist Device Evaluation
 2 Topics
Learning Objectives
Lecture – Keith Aaronson, MD, University of Michigan
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
Session VII: Translational Pathway for Interventional Devices for Heart Failure
 1 Topic
Session VII Topics
Overview of Interventional Devices for Heart Failure
 2 Topics
Learning Objectives
Lecture – William Abraham, MD, Ohio State University
Current Landscape and Future Direction – Percutaneous Ventricular Assist Devices
 2 Topics
Learning Objectives
Lecture – William O’Neill, MD
Current Landscape and Future Direction of Neuromodulation Heart Failure Therapies
 2 Topics
Learning Objectives
Lecture – Horst Sievert, MD
Current Landscape and Future Direction – Intracardiac Shunts and Ventricular Remodeling Therapies
 2 Topics
Learning Objectives
Lecture – Gregg Stone, MD, Columbia University
Interventional Devices for Heart Failure - Non-Clinical Evaluation
 2 Topics
Learning Objectives
Lecture – Navin Kapur, MD, Tufts Medical Center
Interventional Devices for Heart Failure – FDA Perspective
 2 Topics
Learning Objectives
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
Learning Objectives
Lecture – Brian Whisenant, MD, University of Utah
Current and Future Left Atrial Appendage Imaging Modalities to Optimize LAA Closure
 2 Topics
Learning Objectives
Lecture – Dee Dee Wang, MD, Henry Ford Hospital
Left Atrial Appendage Closure Devices – FDA Perspective
 2 Topics
Learning Objectives
Lecture – Rachel Neubrander, PhD, FDA
Panel Discussion
 1 Topic
TCT 2019 Left Atrial Appendage Closure
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ISCTR Mission

Translational Pathways for Cardiovascular Devices ISCTR Mission

Nabil Dib, MD, Msc, FACC, FESC
Professor of Medicine
Director of Cardiovascular Research, Dignity Health

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