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Translational Pathways for Cardiovascular Devices

Online Course

80 Multidisciplinary Lectures presented by Innovators, Industry, Regulatory (FDA & EU), Reimbursement, Practice Guideline, and Patients

Target Audience:

Inventors, Clinical and Basic Scientists, Interventional Cardiologists, Medical Students, Engineers, Industry, Regulators, Payers, and Investors

Table of Contents

Welcome
Meet the Course Directors
  • Spencer King, MD, Emory University
  • Anthony DeMaria, MD, University of California San Diego
  • Nabil Dib, MD, ISCTR (View for free online)
Introduction
Mission Statement
The Translational Pathway to Expedite Scientific Discovery to Patients
Meet the Legends of Innovation Panel Discussion
  • John Simpson, MD, Avinger
  • Alain Cribier, MD, University of Rouen
  • Gary Roubin, MD, Brookwood Baptist Health
  • Richard Schatz, MD, Scripps Clinic
  • Julio Palmaz, MD, San Francisco
  • David Reuter, MD, PhD, Seattle Children’s
  • Gregg Sutton, Surmodics, Inc.
  • Bram Zuckerman, MD, FDA
  • Gregg Stone, MD, Mt. Sinai
  • Spencer King, MD, Emory University
  • Magdi Yacoub, MD, Imperial College
  • James Muller, MD, InfraReDx
  • Charles Simonton, MD, Abbott Vascular
  • Neal Fearnot, PhD, Cook Group
  • Stan Rowe, NXT Biomedical (View for free online)
Session I: Basic Knowledge for CV Devices Development
Topic 1: Concept/Innovation

Choosing an Innovative Concept

  • Todd Brinton, MD, Edwards Lifesciences
Topic 2: Intellectual Property

Intellectual Property

  • James Inskeep, Inskeep Intellectual Property Group
Topic 3: Business Plan, Product Development, and Fundraising

Business Plan, Product Development, and Fundraising

  • Stan Rowe, NXT Biomedical
Topic 4: Product Manufacturing

Requirements for Medical Device Manufacturing & Iteration – FDA Point of View

  • Brad Quinn, FDA

Requirements for Medical Device Manufacturing & Iteration

  • Richard Rapoza, PhD, Abbott Vascular
Topic 5: Preclinical Evaluation/Animal Model

Advanced Cardiac Anatomy – Application in Translational Research Tailored to Current and Future Technology

  • Renu Virmani, MD, CV Path Institute

Introduction to the Cardiac Cath Lab

  • Morton Kern, MD, University of California Irvine & Long Beach Veterans Administration Medical Center

Large Animal Model for Heart Failure, Valvular Disease, Coronary Artery Disease, and Device Testing

  • Daniel Burkhoff, MD, Columbia University

Pre-Clinical Study Design & Endpoints for Device Evaluation – FDA Point of View

  • Judith Davis, DVM, MS, FDA

Pre-Clinical Study Design & Endpoints for Device Evaluation – Investigator Point of View

  • Renu Virmani, MD, CV Path Institute
Topic 6: Early Feasibility

Early Feasibility Studies for Device Evaluation

  • Andrew Farb, MD, FDA

Current Challenges & Future Direction for Human Early Feasibility Study for Device Evaluation – Industry Point of View

  • David Reuter, MD, Seattle Children’s Hospital
Topic 7: Biostatistics

Basic in Statistics – Clinical Study Design for Translational Research

  • Chris Mullin, PhD, NAMSA

Basic Statistical Concepts

  • Chris Mullin, PhD, NAMSA

Sample Size and Power

  • Chris Mullin, PhD, NAMSA

Sensitivity and Specificity

  • Chris Mullin, PhD, NAMSA

Common Study Design

  • Chris Mullin, PhD, NAMSA

Phases of Translational Research

  • Chris Mullin, PhD, NAMSA

Statistics for Evaluation of Cardiovascular Diagnostic Devices

  • Chris Mullin, PhD, NAMSA

Pre-Clinical & Clinical Trial Design & Endpoints of Fast Track to Device Approval

  • Roseann White, PhD, Duke Research Institute

Advanced Statistical Methods for Translational Research

  • Chris Mullin, PhD, NAMSA 

Clinical Endpoints/Surrogate Endpoints

  • Roseann White, PhD, Duke Research Institute
Topic 8: Regulatory Approval

Regulatory Requirement for Marketing Approval

Regulatory Review of Cardiovascular Diagnostic Devices – FDA Perspective

  • Marco Cannella, PhD, FDA

Regulatory Review of Cardiovascular Devices – European Regulatory Perspective

Topic 9: Reimbursement

CMS Criteria for Reimbursement for Cardiovascular Innovation

  • Joseph Chin, MD, Centers for Medicare and Medicaid Services (CMS)

Reimbursement for Diagnostic Devices

  • Lori Ashby, Centers for Medicare and Medicaid Services (CMS)
Topic 10: Practice Guideline

Practice Guideline Requirement for New Technology

  • Alice Jacobs, MD, Boston University 

Guideline Requirements for Diagnostic Devices

  • Roxana Mehran, MD, Icahn School of Medicine, Mount Sinai
Topic 11: Technology Adoption

Adoption of Technology

  • Ian Meredith, MD, Boston Scientific

Global Heart Health, Implications for Translational Research

  • Salim Yusuf, World Federation of Cardiology
Topic 12: Conflict of Interest

 Conflict of Interest and Product Development

  • Anthony DeMaria, MD, University of Southern California San Diego
Topic 13: Patients

The Patients Voice

  • Mark Mercola, PhD, Stanford Cardiovascular Institute
Panel Discussions
  • 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 II: Translational Pathway for Transcatheter Aortic Valve Replacement
The Clinical Need for Innovative Treatment for Aortic Valve Disease
  • Martin Leon, MD, Columbia University
The Methods for TAVR Development
  • Stan Rowe, Edwards Lifesciences
The Endpoints for TAVR Development
  • Ori Ben-Yehuda, MD, Cardiovascular Research Foundation
Current Challenges & Future Direction for AV Development & Iteration – FDA Point of View
  • Nicole Ibrahim, PhD, FDA
Current Challenges & Future Direction for AV Development & Iteration – Industry Point of View
  • Stan Rowe, Edwards Lifesciences
TAVR Development from Concept to First In Man
TAVR Development from First In Man to Phase 3 and Beyond
Panel Discussions
  • 2017 Valve Disease/TAVR
  • 2016 Aortic Valve Development
Session III: Translational Pathway for Transcatheter Mitral/Tricuspid Valve Devices
The Clinical Need for Innovative Treatment for Aortic Valve Disease
  • Michael Mack, MD, Baylor Scott & White Health
The Methods for Translational Mitra/Tricuspid Valve Device Development
  • Michael Mack, MD, Baylor Scott & White Health
The Endpoints for Transcatheter Mitral/Tricuspid Valve Device Development
  • Blasé Carabello, MD, East Carolina University
Current Challenges & Future Direction for Mitral/Tricuspid Valve Device Development & Iteration FDA Point of View
  • John Laschinger, MD, FDA
Current Challenges & Future Direction for Mitral/Tricuspid Valve Device Development & Iteration Industry Point of View
  • Patricia Todd, Edwards Lifesciences
Unmet Clinical Needs for Tricuspid Valve Interventions
  • Carlos Sanchez, MD, Ohio Health-Riverside Methodist Hospital
Current Imaging Limitations for the Advancement of Tricuspid Valve Interventions
  • Rebecca Hahn, MD, Columbia University Medical Center
Tricuspid Valve Interventions: Challenges from the Regulatory Perspective
  • Changfu Wu, PhD, FDA
Panel Discussions
  • 2019 Structural Heart Intervention Imaging
  • 2017 MV/TV Transcatheter Repair/Replacement
  • 2016 MV/TV Development
Session IV: Translational Pathway for Coronary Stent
The Clinical Need for Innovative Coronary Stent
  • Gregg Stone, MD, Icahn School of Medicine, Mount Sinai
The Methods for Coronary Stent Development
  • Chuck Simonton, MD, Abbott Vascular
The Endpoints for Coronary Stent Development
  • Donald Cutlip, MD, Beth Israel-Deaconess Medical Center
Current Challenges & Future Direction for Coronary Stent Development & Iteration – FDA Point of View
  • Michael John, MPH, FDA
Current Challenges & Future Direction for Coronary Stent Development & Iteration – Industry Point of View
  • Chuck Simonton, MD, Abbott Vascular
Unmet Clinical Needs, Value Added & Future Direction in CT Lesion Assessment
  • James Min, MD, Weill Cornell Medicine
Unmet Clinical Needs, Current & Future Direction in Intracoronary Physiology & Imaging Assessment
  • Morton Kern, MD, University of California Irvine & Long Beach Veterans Administration Medical Center
Advances in the Assessment of High-Risk Coronary Lesions – Non-Clinical Evaluation
  • Robert Safian, MD, Center for Innovation & Research in Cardiovascular Diseases (CIRC)
Advances in the Assessment of High-Risk Coronary Lesions – FDA Perspective
  • Shawn Forrest, FDA
Revascularization & Devices for Complex Coronary Lesions – Calcified & Total Occlusions – Unmet Clinical Needs/Future Directions
  • Ajay Kirtane, MD, Columbia University Medical Center
Revascularization & Devices for Complex Coronary Lesions – Calcified & Total Occlusions – Non-Clinical Evaluation
  • Kevin Croce, MD, PhD, Harvard Medical School
Revascularization & Devices for Complex Coronary Lesions – Calcified & Total Occlusions – FDA Perspective
  • Lydia Glaw, PhD, FDA
Panel Discussions
  • 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 V: Translational Pathway for Catheter Ablation
The Clinical Need for the Treatment of Arrhythmia Innovative Catheter Ablation
  • Douglas Packer, MD, Mayo Clinic
Methods for Catheter Ablation Development
  • Douglas Packer, MD, Mayo Clinic
The Endpoints for Catheter Ablation Development
  • Marco Cannella, PhD, FDA
Current Challenges & Future Direction for Catheter Ablation Development & Iteration – FDA Point of View
  • Mark Fellman, MS, FDA
Current Challenges & Future Direction for Catheter Ablation Development & Iteration – Industry Point of View
  • Uri Yaron, PhD, Biosense Webster at Johnson & Johnson
Panel Discussions
  • 2017 Arrhythmia/Catheter Ablation
  • 2016 Catheter Ablation Development
Session VI: Translational Pathway for Ventricular Assist Devices
Ventricular Assist Devices, the Windy Road to Recovery
  • Sir Magdi Yacoub, MD, Imperial College, England
The Methods for Left Ventricular Assist Devices Development
  • Francis Pagani, MD, PhD, University of Michigan
The Endpoints for Left Ventricular Device Evaluation
  • Keith Aaronson, MD, University of Michigan
Panel Discussions
  • 2018 Translational Pathway for LV Assist Devices
  • 2017 CHF/Ventricular Assist Devices
Session VII: Translational Pathway for Interventional Devices for Heart Failure
Overview of Interventional Devices for Heart Failure
  • William Abraham, MD, Ohio State University
 Current Landscape & Future Direction – Percutaneous Ventricular Assist Devices
  • William O’Neill, MD, Henry Ford Hospital
Current Landscape & Future Direction of Neuromodulation Heart Failure Therapies
  • Horst Sievert, MD, CardioVascular Center, Germany
Current Landscape & Future Direction – Intracardiac Shunts & Ventricular Remodeling Therapies
  • Gregg Stone, MD, Icahn School of Medicine, Mount Sinai
Interventional Devices for Heart Failure – Non-Clinical Evaluation
  • Navin Kapur, MD, Tufts Medical Center
Interventional Devices for Heart Failure – FDA Perspective
  • Ileana Piña, MD, Montefiore Einstein Center
Panel Discussions
  • 2019 Interventional Devices for Heart Failure
Session VIII: Translational Pathway for Left Atrial Appendage Closure Devices
Unmet Clinical Needs/Current and Future Direction
  • Brian Whisenant, MD, University of Utah
Current & Future Left Atrial Appendage Imaging Modalities to Optimize LAA Closure
  • Dee Dee Wang, MD, Henry Ford Hospital
Left Atrial Appendage Closure Devices – FDA Perspective
  • Rachel Neubrander, PhD, FDA
Panel Discussions
  • 2019 Left Atrial Appendage Closure Devices