Translational Pathways for Cardiovascular Devices

INTRODUCTION
Welcome from the Course Directors
3 Topics
Course Director Nabil Dib, MD
Course Director Spencer B. King, MD
Course Director Anthony N. DeMaria, MD
Course Description
8 Topics
Fulfill Unmet Educational Need (Knowledge Gap)
Translational Pathway for Trans Aortic Valve Replacement-TAVR
FlowFusion ND Infusion Catheter
U.S. Regulatory Device Evaluation
Translational Pathways for Cardiovascular Devices
Translational Pathway for Cardiovascular Therapy
Who should take this course?
Course Sessions
Translational Pathway to Expedite Scientific Discovery to Patients
Meet the Legends of Innovation
SESSION I: BASIC KNOWLEDGE FOR CV DEVICES DEVELOPMENT
Session I Introduction: Medical Device Development
Concept/Innovation
1 Topic | 1 Quiz
Lecture – Todd Brinton, MD, Edward’s Lifesciences
Translational Pathways for Cardiovascular Devices – Session 1: Concept / Innovation – Choosing an Innovative Concept – Todd Brinton Practice Quiz
Intellectual Property
1 Topic | 1 Quiz
Lecture – James Inskeep, Patent Attorney
Translational Pathways for Cardiovascular Devices – Session 1: Intellectual Property – James Inskeep Practice Quiz
Business Plan, Development, and Fundraising
1 Topic | 1 Quiz
Lecture – Stan Rowe, Edward’s Lifesciences
Translational Pathways for Cardiovascular Devices – Session 1: Business Plan, Product Development, and Fundraising – Stan Rowe Practice Quiz
Product Manufacturing
4 Topics | 2 Quizzes
Learning Objectives
Lecture – Brad Quinn, FDA
Translational Pathways for Cardiovascular Devices – Session 1: Product Manufacturing – Requirements for Medical Device Manufacturing and Iteration FDA Point of View – Brad Quinn Practice Quiz
Translational Pathways for Cardiovascular Devices – Session 1: Product Manufacturing – Requirements for Medical Device Manufacturing and Iteration FDA Point of View – Brad Quinn Practice Quiz
Lecture – Richard Rapoza, PhD, Abbott Vascular
Translational Pathways for Cardiovascular Devices – Session 1: Requirements for Medical Device Manufacturing and Iteration Industry Point of View – Richard Rapoza Practice Quiz
Preclinical Evaluation
7 Topics | 4 Quizzes
Lecture – Renu Virmani, MD, CV Path Institute
Translational Pathways for Cardiovascular Devices – Session 1: Preclinical Evaluation -Advanced Cardiac Anatomy – Application in Translational Research Tailored to Current and Future Technology – Renu Virmani Practice Quiz
Translational Pathways for Cardiovascular Devices – Session 1: Preclinical Evaluation -Advanced Cardiac Anatomy – Application in Translational Research Tailored to Current and Future Technology – Renu Virmani Practice Quiz
Lecture – Daniel Burkhoff, MD, Colombia University
Translational Pathways for Cardiovascular Devices – Session 1: Large Animal Model for Heart Failure, Valvular Disease, Coronary Artery Disease, and Device Testing – Daniel Burkhoff Practice Quiz
Translational Pathways for Cardiovascular Devices – Session 1: Large Animal Model for Heart Failure, Valvular Disease, Coronary Artery Disease, and Device Testing – Daniel Burkhoff Practice Quiz
Lecture – Judith Davis, DVM, MS, FDA
Translational Pathways for Cardiovascular Devices – Session 1: Pre-Clinical Study Design and Endpoints for Device Evaluation FDA Point Of View – Judith Davis Practice Quiz
Translational Pathways for Cardiovascular Devices – Session 1: Pre-Clinical Study Design and Endpoints for Device Evaluation FDA Point Of View – Judith Davis Practice Quiz
Lecture – Renu Virmani, MD, CV Path Institute
Translational Pathways for Cardiovascular Devices – Session 1: Pre-Clinical Study Design and Endpoints for Device Evaluation Investigator Point Of View – Renu Virmani Practice Quiz
Early Feasibility Study
3 Topics | 2 Quizzes
Lecture – Andrew Farb, MD, FDA
Translational Pathways for Cardiovascular Devices – Session 1: Early Feasibility Study – Early Feasibility Studies for Device Evaluation – Andrew Farb Practice Quiz
Translational Pathways for Cardiovascular Devices – Session 1: Early Feasibility Study – Early Feasibility Studies for Device Evaluation – Andrew Farb Practice Quiz
Lecture – David Reuter, MD, Seattle Children’s Hospital
Translational Pathways for Cardiovascular Devices – Session 1: Current Challenges and Future Direction for Human Early Feasibility Study for Device Evaluation – Industry Point of View – David Reuter Practice Quiz
Biostatistics
19 Topics | 10 Quizzes
Lecture – Chris Mullin, PhD, NAMSA
Translational Pathways for Cardiovascular Devices – Session 1: Biostatistics – Basic in Statistics – Clinical Study Design for Translational Research – Chris Mullin Practice Quiz
Translational Pathways for Cardiovascular Devices – Session 1: Biostatistics – Basic in Statistics – Clinical Study Design for Translational Research – Chris Mullin Practice Quiz
Lecture – Chris Mullin, PhD, NAMSA
Translational Pathways for Cardiovascular Devices – Session 1: Basic in Statistics- Basic Statistical Concepts – Chris Mullin Practice Quiz
Translational Pathways for Cardiovascular Devices – Session 1: Basic in Statistics- Basic Statistical Concepts – Chris Mullin Practice Quiz
Lecture – Chris Mullin, PhD, NAMSA
Translational Pathways for Cardiovascular Devices – Session 1: Basic in Statistics – Sample Size and Power – Chris Mullin Practice Quiz
Translational Pathways for Cardiovascular Devices – Session 1: Basic in Statistics – Sample Size and Power – Chris Mullin Practice Quiz
Lecture – Chris Mullin, PhD, NAMSA
Translational Pathways for Cardiovascular Devices – Session 1: Basic in Statistics – Sensitivity and Specificity – Chris Mullin Practice Quiz
Translational Pathways for Cardiovascular Devices – Session 1: Basic in Statistics – Sensitivity and Specificity – Chris Mullin Practice Quiz
Lecture – Chris Mullin, PhD, NAMSA
Translational Pathways for Cardiovascular Devices – Session 1: Basic in Statistics – Common Study Design – Chris Mullin Practice Quiz
Translational Pathways for Cardiovascular Devices – Session 1: Basic in Statistics – Common Study Design – Chris Mullin Practice Quiz
Lecture – Chris Mullin, PhD, NAMSA
Translational Pathways for Cardiovascular Devices – Session 1: Basic in Statistics – Phases of Translational Research – Chris Mullin Practice Quiz
Translational Pathways for Cardiovascular Devices – Session 1: Basic in Statistics – Phases of Translational Research – Chris Mullin Practice Quiz
Lecture – Chris Mullin, PhD, NAMSA
Translational Pathways for Cardiovascular Devices – Session 1: Statistics for Evaluation of Cardiovascular Diagnostic Devices- Chris Mullin Practice Quiz
Translational Pathways for Cardiovascular Devices – Session 1: Statistics for Evaluation of Cardiovascular Diagnostic Devices- Chris Mullin Practice Quiz
Lecture – Roseann White, PhD, Duke Research Institute
Translational Pathways for Cardiovascular Devices – Session 1: Pre-Clinical and Clinical Trial Design and Endpoints of Fast Track to Device Approval – Roseann White Practice Quiz
Translational Pathways for Cardiovascular Devices – Session 1: Pre-Clinical and Clinical Trial Design and Endpoints of Fast Track to Device Approval – Roseann White Practice Quiz
Lecture – Chris Mullin, PhD, NAMSA
Translational Pathways for Cardiovascular Devices – Session 1: Advanced Statistical Methods for Translational Research- Chris Mullin Practice Quiz
Translational Pathways for Cardiovascular Devices – Session 1: Advanced Statistical Methods for Translational Research- Chris Mullin Practice Quiz
Lecture – Roseann White, PhD, Duke Research Institute
Translational Pathways for Cardiovascular Devices – Session 1: Clinical Endpoints/Surrogate Endpoints – Roseann White Practice Quiz
Regulatory Approval
6 Topics | 3 Quizzes
Lecture – Bram Zuckerman, MD, FDA
Translational Pathways for Cardiovascular Devices – Session 1: Regulatory Approval – Regulatory Requirement for Marketing Approval – Bram Zuckerman Practice Quiz
Translational Pathways for Cardiovascular Devices – Session 1: Regulatory Approval – Regulatory Requirement for Marketing Approval – Bram Zuckerman Practice Quiz
FDA Perspective on Transformative Regulatory Pathways and Device Innovation
Lecture – Marco Cannella, PhD, FDA
Translational Pathways for Cardiovascular Devices – Session I: Regulatory Review of Cardiovascular Diagnostic devices – FDA Perspective – Marco Cannella Practice Quiz
Translational Pathways for Cardiovascular Devices – Session I: Regulatory Review of Cardiovascular Diagnostic devices – FDA Perspective – Marco Cannella Practice Quiz
Lecture – Robert Byrne, MD, Heart Centre, Germany
Translational Pathways for Cardiovascular Devices – Session 1: Regulatory Review of Cardiovascular Devices: European Regulatory Perspective – Robert Byrne Practice Quiz
Reimbursement
3 Topics | 2 Quizzes
Lecture – Joseph Chin, MD, CMS
Translational Pathways for Cardiovascular Devices – Session 1: Reimbursement – CMS Criteria for Reimbursement for Cardiovascular Innovation – Joseph Chin Practice Quiz
Translational Pathways for Cardiovascular Devices – Session 1: Reimbursement – CMS Criteria for Reimbursement for Cardiovascular Innovation – Joseph Chin Practice Quiz
Lecture – Lori Ashby, CMS
Translational Pathways for Cardiovascular Devices – Session I: Reimbursement for Diagnostic Devices – Lori Ashby Practice Quiz
Practice Guideline
3 Topics | 2 Quizzes
Lecture – Alice Jacobs, MD, Boston University
Translational Pathways for Cardiovascular Devices – Session 1: Practice Guideline – Practice Guideline Requirement for New Technology – Alice Jacobs Practice Quiz
Translational Pathways for Cardiovascular Devices – Session 1: Practice Guideline – Practice Guideline Requirement for New Technology – Alice Jacobs Practice Quiz
Lecture – Roxana Mehran, MD, Icahn School of Medicine, Mount Sinai
Translational Pathways for Cardiovascular Devices – Session I: Guideline Requirement for Diagnostic Devices – Roxanna Mehran Practice Quiz
Technology Adoption
7 Topics | 2 Quizzes
Adoption of Technology
Learning Objectives
Lecture – Ian Meredith, MD, Boston Scientific
Translational Pathways for Cardiovascular Devices – Session 1: Technology Adoption – Adoption of Technology – Ian Meredith Practice Quiz
Translational Pathways for Cardiovascular Devices – Session 1: Technology Adoption – Adoption of Technology – Ian Meredith Practice Quiz
Global Heart Health, Implications for Translational Research
Learning Objectives
Lecture – Salim Yusuf, D. Phil, World Federation of Cardiology
Translational Pathways for Cardiovascular Devices – Session 1: Global Heart Health, Implications for Translational Research – Salim Yusuf Practice Quiz
Conflict of Interest
3 Topics | 1 Quiz
Conflict of Interest and Product Development
Learning Objectives
Lecture – Anthony DeMaria, MD, UCSD
Translational Pathways for Cardiovascular Devices – Session I: Conflict of Interest – Anthony DeMaria Practice Quiz
Patients
3 Topics | 1 Quiz
The Patients Voice
Learning Objectives
Lecture – Mark Mercola, PhD, Stanford Cardiovascular Institute
Translational Pathways for Cardiovascular Devices – Session 1: Patients Voice – Mark Mercola Practice Quiz
Panel Discussions
5 Topics
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 I: Basic Knowledge for CV Devices Development Final Quiz
1 Quiz
Translational Pathways for Cardiovascular Devices – Session I: Basic Knowledge for CV Devices Development Final Quiz
Basic Knowledge for Medical Device Development – End
Session II
SESSION II: TRANSLATIONAL PATHWAY FOR TRANSCATHETER AORTIC VALVE
Session II: Translational Pathway for Transcatheter Aortic Valve
1 Topic
Session II Topics
The Clinical Need for Innovative Treatment for Aortic Valve Disease
2 Topics
Learning Objectives
Lecture – Martin Leon, MD, Columbia University
The Methods for Transcatheter Aortic Valve Development
2 Topics
Learning Objectives
Lecture – Stan Rowe, Edwards’s Lifesciences
The Endpoints for Transcatheter Aortic Valve Development
2 Topics
Learning Objectives
Lecture – Ori Ben-Yehuda, MD, Cardiovascular Research Foundation
Current Challenges and Future Direction for Aortic Valve Development and Iteration – FDA Point of View
2 Topics
Learning Objectives
Lecture – Nicole Ibrahim, PhD, FDA
Current Challenges and Future Direction for Aortic Valve Development and Iteration – Industry Point of View
2 Topics
Learning Objectives
Lecture – Stan Rowe, Edward’s Lifesciences
The TAVR Development from Concept to First in Man
2 Topics
Learning Objectives
Lecture – Alain Cribier, MD, University of Rouen, France
The TAVR Development from First in Man to Phase 3 and Beyond
2 Topics
Learning Objectives
Lecture – Martin Leon, MD, Columbia University
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
SESSION III: TRANSLATIONAL PATHWAY FOR TRANSCATHETER MITRAL/TRICUSPID VALVE DEVICES
Session III: Translational Pathway for Transcatheter Mitral/Tricuspid Valve Devices
1 Topic
Session III Topics
The Clinical Need for Innovative Treatment for Mitral/Tricuspid Valve Disease
2 Topics
Learning Objectives
Lecture – Michael Mack, MD, Baylor Scott & White Health
The Methods for Translational Mitral/Tricuspid Valve Device Development
2 Topics
Learning Objectives
Lecture – Michael Mack, MD, Baylor Scott & White Health
The Endpoints for Transcatheter Mitral/Tricuspid Valve Device Development
2 Topics
Learning Objectives
Lecture – Blasé Carabello, MD, East Carolina University
Current Challenges and Future Direction for Mitral/Tricuspid Valve Device Development and Iteration – FDA Point of View
2 Topics
Learning Objectives
Lecture – John Laschinger, MD, FDA
Current Challenges and Future Direction for Mitral/Tricuspid Valve Device Development and Iteration – Industry Point of View
2 Topics
Learning Objectives
Lecture – Patricia Todd, Edward’s Lifesciences
Unmet Clinical Needs for Tricuspid Valve Interventions
2 Topics
Learning Objectives
Lecture – Carlos Sanchez, MD
Current Imaging Limitations for the Advancement of Tricuspid Valve Interventions
2 Topics
Learning Objectives
Lecture – Rebecca Hahn, MD, Columbia University Medical Center
Tricuspid Valve Interventions: Challenges from the Regulatory Perspective
2 Topics
Learning Objectives
Lecture – Changfu Wu, PhD, FDA
Panel Discussions
3 Topics
2019 Structural Heart Intervention Imaging
2017 MV/TV Transcatheter Repair/Replacement
2016 MV/TV Development
Session III: Translational Pathway For Transcatheter Mitral/Tricuspid Valve Devices Final Quiz
1 Quiz
Translational Pathways for Cardiovascular Devices – Session III: Translational Pathway For Transcatheter Mitral/Tricuspid Valve Devices Final Quiz
Session III: Translational Pathway for Transcatheter Mitral/Tricuspid Valve Devices – End
Session IV
SESSION IV: TRANSLATIONAL PATHWAY FOR CORONARY STENT
Session IV: Translational Pathway for Coronary Stent
1 Topic
Session IV Topics
The Clinical Need for Innovative Coronary Stent
2 Topics
Learning Objectives
Lecture – Gregg Stone, MD, Columbia University
The Methods for Coronary Stent Development
2 Topics
Learning Objectives
Lecture – Charles Simonton, MD, Abbott Vascular
The Endpoints for Coronary Stent Development
2 Topics
Learning Objectives
Lecture – Donald Cutlip, MD, Beth Israel-Deaconess
Current Challenges and Future Direction for Coronary Stent Development and Iteration – FDA Point of View
2 Topics
Learning Objectives
Lecture – Michael John, MPH, FDA
Current Challenges and Future Direction for Coronary Stent Development and Iteration – Industry Point of View
2 Topics
Learning Objectives
Lecture – Charles Simonton, MD, Abbott Vascular
Unmet Clinical Needs, Value Added and Future Direction in CT Lesion Assessment
2 Topics
Learning Objectives
Lecture – James Min, MD, Weill Cornell Medicine
Unmet Clinical Needs, Current and Future Direction in Intracoronary Physiology and Imaging Assessment
2 Topics
Learning Objectives
Lecture – Morton Kern, MD
Advances in the Assessment of High-Risk Coronary Lesions – Non-Clinical Evaluation
2 Topics
Learning Objectives
Lecture – Robert Safian, MD
Advances in the Assessment of High-Risk Coronary Lesions – FDA Perspectives
2 Topics
Learning Objectives
Lecture – Shawn Forrest, FDA
Revascularization and Devices for Complex Coronary Lesions – Calcified, Total Occlusion – Unmet Clinical Needs – Current and Future Direction
2 Topics
Learning Objectives
Lecture – Ajay Kirtane, MD, Columbia University Medical Center
Revascularization and Devices for Complex Coronary Lesions – Calcified, Total Occlusion – Non-Clinical Evaluation
2 Topics
Learning Objectives
Lecture – Kevin Croce, MD, PhD, Harvard Medical School
Revascularization and Devices for Complex Coronary Lesions – Calcified, Total Occlusion – FDA Perspectives
2 Topics
Learning Objectives
Lecture – Lydia Glaw, PhD, FDA
Panel Discussions
4 Topics
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 IV: Translational Pathway for Coronary Stent Development Final Quiz
1 Quiz
Translational Pathways for Cardiovascular Devices – Session IV: Translational Pathway for Coronary Stent Development Final Quiz
Session IV: Translational Pathway for Coronary Stent – End
Session V
SESSION V: TRANSLATIONAL PATHWAY FOR CATHETER ABLATION
Session V: Translational Pathway for Catheter Ablation
1 Topic
Session V Topics
The Clinical Need for the Treatment of Arrhythmia Innovative Catheter Ablation  
2 Topics
Learning Objectives
Lecture – Douglas Packer, MD, Mayo Clinic
Methods for Catheter Ablation Development
2 Topics
Learning Objectives
Lecture – Douglas Packer, MD, Mayo Clinic
The Endpoints for Catheter Ablation Development
2 Topics
Learning Objectives
Lecture – Marco Cannella, PhD, FDA
Current Challenges and Future Direction for Catheter Ablation Development and Iteration – FDA Point of View  
2 Topics
Learning Objectives
Lecture – Mark Fellman, MS, FDA
Current Challenges and Future Direction for Catheter Ablation Development and Iteration – Industry Point of View  
2 Topics
Learning Objectives
Lecture – Uri Yaron, PhD, Johnson & Johnson
Panel Discussions
2 Topics
2017 Arrhythmia/Catheter Ablation
2016 Catheter Ablation Development
Session V: Translational Pathway for Catheter Ablation Final Quiz
1 Quiz
Translational Pathways for Cardiovascular Devices – Session V: Translational Pathway for Catheter Ablation Final Quiz
Session V: Translational Pathway for Catheter Ablation – End
Session VI
SESSION VI: TRANSLATIONAL PATHWAY FOR VENTRICULAR ASSIST DEVICES
Session VI: Translational Pathway for Ventricular Assist Devices
1 Topic
Session VI Topics
Ventricular Assist Devices, The Windy Road to Recovery
2 Topics
Learning Objectives
Lecture – Sr. Magdi Yacoub, MD, Imperial College, London
The Methods for Left Ventricular Assist Devices Development
2 Topics
Learning Objectives
Lecture – Francis Pagani, MD, University of Michigan
The Endpoints for Left Ventricular Assist Device Evaluation
2 Topics
Learning Objectives
Lecture – Keith Aaronson, MD, University of Michigan
Panel Discussions
2 Topics
2018 Translational Pathway for LV Assist Devices
2017 CHF/Ventricular Assist Devices
Session VI: Translational Pathway for Ventricular Assist Devices Final Quiz
1 Quiz
Translational Pathways for Cardiovascular Devices – Session VI: Translational Pathway for Ventricular Assist Devices Final Quiz
Session VI: Translational Pathway for Ventricular Assist Devices – End
Session VII
SESSION VII: TRANSLATIONAL PATHWAY FOR INTERVENTIONAL DEVICES FOR HEART FAILURE
Session VII: Translational Pathway for Interventional Devices for Heart Failure
1 Topic
Session VII Topics
Overview of Interventional Devices for Heart Failure
2 Topics
Learning Objectives
Lecture – William Abraham, MD, Ohio State University
Current Landscape and Future Direction – Percutaneous Ventricular Assist Devices
2 Topics
Learning Objectives
Lecture – William O’Neill, MD
Current Landscape and Future Direction of Neuromodulation Heart Failure Therapies
2 Topics
Learning Objectives
Lecture – Horst Sievert, MD
Current Landscape and Future Direction – Intracardiac Shunts and Ventricular Remodeling Therapies
2 Topics
Learning Objectives
Lecture – Gregg Stone, MD, Columbia University
Interventional Devices for Heart Failure – Non-Clinical Evaluation
2 Topics
Learning Objectives
Lecture – Navin Kapur, MD, Tufts Medical Center
Interventional Devices for Heart Failure – FDA Perspective
2 Topics
Learning Objectives
Lecture – Ileana Piña, MD, FDA
Panel Discussion
1 Topic
TCT 2019 Heart Failure
Session VII: Translational Pathway for Interventional Devices for Heart Failure Final Quiz
1 Quiz
Translational Pathways for Cardiovascular Devices – Session VII: Translational Pathway for Interventional Devices for Heart Failure Final Quiz
Session VII: Translational Pathway for Interventional Devices for Heart Failure – End
Session VIII
SESSION VIII: TRANSLATIONAL PATHWAY FOR LEFT ATRIAL APPENDAGE CLOSURE DEVICES
Session VIII: Translational Pathway for Left Atrial Appendage Closure Devices
1 Topic
Session VIII Topics
Unmet Clinical Needs/Current and Future Direction
2 Topics
Learning Objectives
Lecture – Brian Whisenant, MD, University of Utah
Current and Future Left Atrial Appendage Imaging Modalities to Optimize LAA Closure
2 Topics
Learning Objectives
Lecture – Dee Dee Wang, MD, Henry Ford Hospital
Left Atrial Appendage Closure Devices – FDA Perspective
2 Topics
Learning Objectives
Lecture – Rachel Neubrander, PhD, FDA
Panel Discussion
1 Topic
TCT 2019 Left Atrial Appendage Closure
Session VIII: Translational Pathway for Left Atrial Appendage Closure Devices Final Quiz
1 Quiz
Translational Pathways for Cardiovascular Devices – Session VIII: Translational Pathway for Left Atrial Appendage Closure Devices Final Quiz
Session VIII: Translational Pathway for Left Atrial Appendage Closure Devices – End
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Translational Pathway to Expedite Scientific Discovery to Patients

Translational Pathways for Cardiovascular Devices Translational Pathway to Expedite Scientific Discovery to Patients

Robert Califf, MD, FDA

Food and Drug Administration

Learning Objectives

  • Recognize that creativity and innovation are critical for our patients and economy
  • Recognize the future of merging technology of devices, biologics and drugs
  • Understand the importance of precision medicine
  • Understand the concept of ecosystem
  • Learn the concept of integrated health system
  • Learn the importance of the preclinical data
  • Learn that evidence collected should be useful for FDA and CMS approval at the same time
  • Recognize the importance of sharing data
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