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
Course Description
- Nabil Dib, MD, ISCTR (View Here)
The Translational Pathway to Expedite Scientific Discovery to Patients
- Robert Califf, MD, FDA (View for free online)
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
- Bram Zuckerman, MD, FDA (View for free online)
Regulatory Review of Cardiovascular Diagnostic Devices – FDA Perspective
- Marco Cannella, PhD, FDA
Regulatory Review of Cardiovascular Devices – European Regulatory Perspective
- Robert Byrne, MD, Heart Center, Germany (View for free online)
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
- Alain Cribier, MD, University of Rouen, France (View for free online)
TAVR Development from First In Man to Phase 3 and Beyond
- Martin Leon, MD, Columbia University (View for free online)
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