Translational Pathways for Cardiovascular Devices

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
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
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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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