Translational Pathways for Cardiovascular Devicesv2

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
Panel Discussions
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The TAVR Development from Concept to First in Man

Translational Pathways for Cardiovascular Devicesv2 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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