• [vc_row row_background_lines=”none”][vc_column width=”2/3″][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:”][vc_column_text]Inventors, Clinical and Basic Scientists, Interventional Cardiologists, Medical Students, Engineers, Industry, Regulators, Payers, and Investors[/vc_column_text][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/”][/vc_column][vc_column width=”1/3″][vc_single_image image=”23580″ img_size=”full”][ultimate_spacer height=”20″ height_on_tabs=”20″ height_on_tabs_portrait=”20″ height_on_mob_landscape=”15″ height_on_mob=”15″][vc_single_image image=”23581″ img_size=”full”][ultimate_spacer height=”20″ height_on_tabs=”20″ height_on_tabs_portrait=”20″ height_on_mob_landscape=”15″ height_on_mob=”15″][/vc_column][/vc_row][vc_row row_background_lines=”none” css=”.vc_custom_1594335588194{margin-bottom: 30px !important;}”][vc_column][eltdf_section_title position=”” overflow=”no” title_tag=”” disable_break_words=”no” title=”Table of Contents”][/vc_column][/vc_row][vc_row equal_height=”yes” row_background_lines=”none” seperator_enable=”seperator_enable_value” seperator_type=”tilt_right_seperator” seperator_position=”bottom_seperator” seperator_svg_height=”6″ css=”.vc_custom_1594338824185{margin-top: 30px !important;margin-bottom: 30px !important;}”][vc_column width=”2/12″][ult_sticky_section sticky_gutter=”120″][eltdf_section_title position=”” overflow=”no” subtitle_tag=”” subtitle=”Welcome”][/ult_sticky_section][/vc_column][vc_column width=”10/12″][vc_row_inner][vc_column_inner width=”1/3″][ult_sticky_section sticky_gutter=”120″][vc_column_text]

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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• Nabil Dib, MD, ISCTR (View Here)

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The Translational Pathway to Expedite Scientific Discovery to Patients

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• Robert Califf, MD, FDA (View for free online)

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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

[/vc_column_text][/ult_sticky_section][/vc_column_inner][vc_column_inner width=”2/3″][vc_column_text]Choosing an Innovative Concept

• Todd Brinton, MD, Edwards Lifesciences

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Topic 2: Intellectual Property

[/vc_column_text][/ult_sticky_section][/vc_column_inner][vc_column_inner width=”2/3″][vc_column_text]Intellectual Property

• James Inskeep, Inskeep Intellectual Property Group

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Topic 3: Business Plan, Product Development, and Fundraising

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• Stan Rowe, NXT Biomedical

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Topic 4: Product Manufacturing

[/vc_column_text][/ult_sticky_section][/vc_column_inner][vc_column_inner width=”2/3″][vc_column_text]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

[/vc_column_text][/ult_sticky_section][/vc_column_inner][vc_column_inner width=”2/3″][vc_column_text]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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• 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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• 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

• Bram Zuckerman, MD, FDA (View for free online)

 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

• Robert Byrne, MD, Heart Center, Germany (View for free online)

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Topic 9: Reimbursement

[/vc_column_text][/ult_sticky_section][/vc_column_inner][vc_column_inner width=”2/3″][vc_column_text]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

[/vc_column_text][/ult_sticky_section][/vc_column_inner][vc_column_inner width=”2/3″][vc_column_text]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

[/vc_column_text][/ult_sticky_section][/vc_column_inner][vc_column_inner width=”2/3″][vc_column_text]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

[/vc_column_text][/ult_sticky_section][/vc_column_inner][vc_column_inner width=”2/3″][vc_column_text] Conflict of Interest and Product Development

• Anthony DeMaria, MD, University of Southern California San Diego

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Topic 13: Patients

[/vc_column_text][/ult_sticky_section][/vc_column_inner][vc_column_inner width=”2/3″][vc_column_text]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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• Alain Cribier, MD, University of Rouen, France (View for free online)

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TAVR Development from First In Man to Phase 3 and Beyond

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• Martin Leon, MD, Columbia University (View for free online)

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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

[/vc_column_text][ultimate_spacer height=”40″ height_on_tabs=”40″ height_on_tabs_portrait=”40″ height_on_mob_landscape=”10″ height_on_mob=”10″][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row equal_height=”yes” row_background_lines=”none” seperator_enable=”seperator_enable_value” seperator_type=”xlarge_triangle_left_seperator” seperator_position=”bottom_seperator” seperator_svg_height=”2″ css=”.vc_custom_1594338160866{margin-top: 30px !important;margin-bottom: 30px !important;}”][vc_column width=”2/12″][ult_sticky_section sticky_gutter=”120″][eltdf_section_title position=”” overflow=”no” subtitle_tag=”” subtitle=”Session IV: Translational Pathway for Coronary Stent”][/ult_sticky_section][/vc_column][vc_column width=”10/12″][vc_row_inner][vc_column_inner width=”1/3″][ult_sticky_section sticky_gutter=”120″][vc_column_text]

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

[/vc_column_text][ultimate_spacer height=”40″ height_on_tabs=”40″ height_on_tabs_portrait=”40″ height_on_mob_landscape=”10″ height_on_mob=”10″][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row equal_height=”yes” row_background_lines=”none” seperator_enable=”seperator_enable_value” seperator_type=”xlarge_triangle_left_seperator” seperator_position=”bottom_seperator” seperator_svg_height=”2″ css=”.vc_custom_1594338160866{margin-top: 30px !important;margin-bottom: 30px !important;}”][vc_column width=”2/12″][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][/vc_column][vc_column width=”10/12″][vc_row_inner][vc_column_inner width=”1/3″][ult_sticky_section sticky_gutter=”120″][vc_column_text]

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

[/vc_column_text][ultimate_spacer height=”40″ height_on_tabs=”40″ height_on_tabs_portrait=”40″ height_on_mob_landscape=”10″ height_on_mob=”10″][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row equal_height=”yes” row_background_lines=”none” seperator_enable=”seperator_enable_value” seperator_type=”xlarge_triangle_left_seperator” seperator_position=”bottom_seperator” seperator_svg_height=”2″ css=”.vc_custom_1594338160866{margin-top: 30px !important;margin-bottom: 30px !important;}”][vc_column width=”2/12″][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][/vc_column][vc_column width=”10/12″][vc_row_inner][vc_column_inner width=”1/3″][ult_sticky_section sticky_gutter=”120″][vc_column_text]

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

[/vc_column_text][ultimate_spacer height=”40″ height_on_tabs=”40″ height_on_tabs_portrait=”40″ height_on_mob_landscape=”10″ height_on_mob=”10″][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row equal_height=”yes” row_background_lines=”none” seperator_enable=”seperator_enable_value” seperator_type=”xlarge_triangle_left_seperator” seperator_position=”bottom_seperator” seperator_svg_height=”2″ css=”.vc_custom_1594338160866{margin-top: 30px !important;margin-bottom: 30px !important;}”][vc_column width=”2/12″][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][/vc_column][vc_column width=”10/12″][vc_row_inner][vc_column_inner width=”1/3″][ult_sticky_section sticky_gutter=”120″][vc_column_text]

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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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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