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  • [eltdf_section_title position=”” overflow=”no” title_tag=”” disable_break_words=”no” subtitle_tag=”” text_font_weight=”” title=”Online Course” subtitle=”Translational Pathways for Cardiovascular Devices” text=”80 Multidisciplinary Lectures presented by Innovators, Industry, Regulatory (FDA & EU), Reimbursement, Practice Guideline, and Patients”][ultimate_spacer height=”40″ height_on_tabs=”40″ height_on_tabs_portrait=”40″ height_on_mob_landscape=”15″ height_on_mob=”15″][eltdf_section_title position=”” overflow=”no” subtitle_tag=”” subtitle=”Target Audience:”]

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

    [ultimate_spacer height=”60″ height_on_tabs=”40″ height_on_tabs_portrait=”40″ height_on_mob_landscape=”15″ height_on_mob=”15″][eltdf_button type=”simple” text=”Go to Online Course” target=”_self” arrow=”yes” icon_pack=”” font_weight=”” text_transform=”” link=”/online-course-translational-pathways-for-cardiovascular-devices/”]
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    [eltdf_section_title position=”” overflow=”no” title_tag=”” disable_break_words=”no” title=”Table of Contents”]
    [ult_sticky_section sticky_gutter=”120″][eltdf_section_title position=”” overflow=”no” subtitle_tag=”” subtitle=”Welcome”][/ult_sticky_section]
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Meet the Course Directors
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  • Spencer King, MD, Emory University
  • Anthony DeMaria, MD, University of California San Diego
  • Nabil Dib, MD, ISCTR (View for free online)
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Course Description
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The Translational Pathway to Expedite Scientific Discovery to Patients
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Meet the Legends of Innovation Panel Discussion
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  • 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, Abiomed
  • Neal Fearnot, PhD, Cook Group
  • Stan Rowe, NXT Biomedical (View for free online)
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Topic 1: Concept/Innovation
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Choosing an Innovative Concept

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

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

  • Stan Rowe, NXT Biomedical
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Topic 4: Product Manufacturing
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Requirements for Medical Device Manufacturing & Iteration – FDA Point of View

  • Brad Quinn, FDA

Requirements for Medical Device Manufacturing & Iteration

  • Richard Rapoza, PhD, Abbott Vascular
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Topic 5: Preclinical Evaluation/Animal Model
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Advanced Cardiac Anatomy – Application in Translational Research Tailored to Current and Future Technology

  • Renu Virmani, MD, CV Path Institute

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
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Topic 6: Early Feasibility
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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
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Topic 7: Biostatistics
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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
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Topic 8: Regulatory Approval
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Regulatory Requirement for Marketing Approval

 FDA Perspective on Transformative Regulatory Pathways & Device Innovation

  • Bram Zuckerman, MD, FDA

Regulatory Review of Cardiovascular Diagnostic Devices – FDA Perspective

  • Marco Cannella, PhD, FDA

Regulatory Review of Cardiovascular Devices – European Regulatory Perspective

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Topic 9: Reimbursement
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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)
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Topic 10: Practice Guideline
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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
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Topic 11: Technology Adoption
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Adoption of Technology

  • Ian Meredith, MD, Boston Scientific

Global Heart Health, Implications for Translational Research

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

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

  • Mark Mercola, PhD, Stanford Cardiovascular Institute
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Panel Discussions
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  • 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
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The Clinical Need for Innovative Treatment for Aortic Valve Disease
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  • Martin Leon, MD, Columbia University
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The Methods for TAVR Development
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  • Stan Rowe, NXT Biomedical
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The Endpoints for TAVR Development
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  • Ori Ben-Yehuda, MD, Cardiovascular Research Foundation
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Current Challenges & Future Direction for AV Development & Iteration – FDA Point of View
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  • Nicole Ibrahim, PhD, FDA
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Current Challenges & Future Direction for AV Development & Iteration – Industry Point of View
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  • Stan Rowe, NXT Biomedical
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TAVR Development from Concept to First In Man
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TAVR Development from First In Man to Phase 3 and Beyond
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Panel Discussions
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  • 2017 Valve Disease/TAVR
  • 2016 Aortic Valve Development
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The Clinical Need for Innovative Treatment for Aortic Valve Disease
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  • Michael Mack, MD, Baylor Scott & White Health
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The Methods for Translational Mitra/Tricuspid Valve Device Development
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  • Michael Mack, MD, Baylor Scott & White Health
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The Endpoints for Transcatheter Mitral/Tricuspid Valve Device Development
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  • Blasé Carabello, MD, East Carolina University
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Current Challenges & Future Direction for Mitral/Tricuspid Valve Device Development & Iteration FDA Point of View
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  • John Laschinger, MD, Edwards Lifesciences
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Current Challenges & Future Direction for Mitral/Tricuspid Valve Device Development & Iteration Industry Point of View
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  • Patricia Todd, Edwards Lifesciences
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Unmet Clinical Needs for Tricuspid Valve Interventions
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  • Carlos Sanchez, MD, Ohio Health-Riverside Methodist Hospital
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Current Imaging Limitations for the Advancement of Tricuspid Valve Interventions
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  • Rebecca Hahn, MD, Columbia University Medical Center
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Tricuspid Valve Interventions: Challenges from the Regulatory Perspective
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  • Changfu Wu, PhD, FDA
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Panel Discussions
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  • 2019 Structural Heart Intervention Imaging
  • 2017 MV/TV Transcatheter Repair/Replacement
  • 2016 MV/TV Development
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The Clinical Need for Innovative Coronary Stent
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  • Gregg Stone, MD, Icahn School of Medicine, Mount Sinai
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The Methods for Coronary Stent Development
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  • Chuck Simonton, MD, Abiomed
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The Endpoints for Coronary Stent Development
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  • Donald Cutlip, MD, Beth Israel-Deaconess Medical Center
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Current Challenges & Future Direction for Coronary Stent Development & Iteration – FDA Point of View
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  • Michael John, MPH, FDA
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Current Challenges & Future Direction for Coronary Stent Development & Iteration – Industry Point of View
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  • Chuck Simonton, MD, Abiomed
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Unmet Clinical Needs, Value Added & Future Direction in CT Lesion Assessment
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  • James Min, MD, Weill Cornell Medicine
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Unmet Clinical Needs, Current & Future Direction in Intracoronary Physiology & Imaging Assessment
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  • Morton Kern, MD, University of California Irvine & Long Beach Veterans Administration Medical Center
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Advances in the Assessment of High-Risk Coronary Lesions – Non-Clinical Evaluation
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  • Robert Safian, MD, Center for Innovation & Research in Cardiovascular Diseases (CIRC)
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Advances in the Assessment of High-Risk Coronary Lesions – FDA Perspective
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  • Shawn Forrest, FDA
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Revascularization & Devices for Complex Coronary Lesions – Calcified & Total Occlusions – Unmet Clinical Needs/Future Directions
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  • Ajay Kirtane, MD, Columbia University Medical Center
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Revascularization & Devices for Complex Coronary Lesions – Calcified & Total Occlusions – Non-Clinical Evaluation
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  • Kevin Croce, MD, PhD, Harvard Medical School
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Revascularization & Devices for Complex Coronary Lesions – Calcified & Total Occlusions – FDA Perspective
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  • Lydia Glaw, PhD, FDA
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Panel Discussions
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  • 2019 Devices for Complex Coronary Lesions
  • 2019 Advances in the Assessment of High Risk Coronary Lesions
  • 2017 CAD/Coronary Stent
  • 2016 Coronary Stent Development
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[ult_sticky_section sticky_gutter=”120″][eltdf_section_title position=”” overflow=”no” subtitle_tag=”” subtitle=”Session V: Translational Pathway for Catheter Ablation”][/ult_sticky_section]
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The Clinical Need for the Treatment of Arrhythmia Innovative Catheter Ablation
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  • Douglas Packer, MD, Mayo Clinic
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Methods for Catheter Ablation Development
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  • Douglas Packer, MD, Mayo Clinic
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The Endpoints for Catheter Ablation Development
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  • Marco Cannella, PhD, FDA
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Current Challenges & Future Direction for Catheter Ablation Development & Iteration – FDA Point of View
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  • Mark Fellman, MS, FDA
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Current Challenges & Future Direction for Catheter Ablation Development & Iteration – Industry Point of View
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  • Uri Yaron, PhD, Formerly Biosense Webster at J&J
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Panel Discussions
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  • 2017 Arrhythmia/Catheter Ablation
  • 2016 Catheter Ablation Development
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[ult_sticky_section sticky_gutter=”120″][eltdf_section_title position=”” overflow=”no” subtitle_tag=”” subtitle=”Session VI: Translational Pathway for Ventricular Assist Devices”][/ult_sticky_section]
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Ventricular Assist Devices, the Windy Road to Recovery
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  • Sir Magdi Yacoub, MD, Imperial College, England
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The Methods for Left Ventricular Assist Devices Development
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  • Francis Pagani, MD, PhD, University of Michigan
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The Endpoints for Left Ventricular Device Evaluation
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  • Keith Aaronson, MD, University of Michigan
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Panel Discussions
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  • 2018 Translational Pathway for LV Assist Devices
  • 2017 CHF/Ventricular Assist Devices
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[ult_sticky_section sticky_gutter=”120″][eltdf_section_title position=”” overflow=”no” subtitle_tag=”” subtitle=”Session VII: Translational Pathway for Interventional Devices for Heart Failure”][/ult_sticky_section]
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Overview of Interventional Devices for Heart Failure
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  • William Abraham, MD, Ohio State University
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 Current Landscape & Future Direction – Percutaneous Ventricular Assist Devices
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  • William O’Neill, MD, Henry Ford Hospital
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Current Landscape & Future Direction of Neuromodulation Heart Failure Therapies
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  • Horst Sievert, MD, CardioVascular Center, Germany
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Current Landscape & Future Direction – Intracardiac Shunts & Ventricular Remodeling Therapies
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  • Gregg Stone, MD, Icahn School of Medicine, Mount Sinai
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Interventional Devices for Heart Failure – Non-Clinical Evaluation
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  • Navin Kapur, MD, Tufts Medical Center
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Interventional Devices for Heart Failure – FDA Perspective
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  • Ileana Piña, MD, Central Michigan University
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Panel Discussions
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  • 2019 Interventional Devices for Heart Failure
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[ult_sticky_section sticky_gutter=”120″][eltdf_section_title position=”” overflow=”no” subtitle_tag=”” subtitle=”Session VIII: Translational Pathway for Left Atrial Appendage Closure Devices”][/ult_sticky_section]
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Unmet Clinical Needs/Current and Future Direction
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  • Brian Whisenant, MD, University of Utah
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Current & Future Left Atrial Appendage Imaging Modalities to Optimize LAA Closure
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  • Dee Dee Wang, MD, Henry Ford Hospital
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Left Atrial Appendage Closure Devices – FDA Perspective
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  • Rachel Neubrander, PhD, FDA
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Panel Discussions
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  • 2019 Left Atrial Appendage Closure Devices
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