Session Tag: online-course
Left Atrial Appendage Closure Devices – FDA Perspective
Rachel Neubrander, PhD Branch Chief, Office of Cardiovascular Devices, FDA Learning Objectives Learn about the non-clinical device assessment Learn the regulatory requirements for left atrial appendage device development Understand selecting a control arm for future studies Learn the evidence gap in LAA closure devices
Current and Future Left Atrial Appendage Imaging Modalities to Optimize LAA Closure
Dee Dee Wang, MD Director, Structural Heart Imaging, Henry Ford Hospital Learning Objectives Understand the different imaging modalities for the Left Atrial Appendage Understand the limitations of imaging the Left Atrial Appendage Learn the importance of knowing the anatomy to understand imaging Recognize that different imaging technology might help with different anatomy
Unmet Clinical Needs/Current and Future Direction
Brian Whisenant, MD Director of Interventional Cardiology, University of Utah Learning Objectives Learn about the limitations of the current closure devices Learn about the limitations of the preclinical model Learn about the different devices used for LAA closure Recognize the future direction and therapeutic approaches
Session VIII: Translational Pathway for Left Atrial Appendage Closure Devices
Session VIII
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Session VII: Translational Pathway for Interventional Devices for Heart Failure – End
Interventional Devices for Heart Failure – FDA Perspective
Ileana Piña, MD Professor of Medicine, Wayne State University, Medical Reviewer, FDA Learning Objectives Understand the complexity of heart failure clinical trials Understand the elements that are important for pivotal heart failure clinical trials Recognize the definition and use of intermediate endpoints in a heart failure clinical trial Learn about the medical device development tool […]
Interventional Devices for Heart Failure – Non-Clinical Evaluation
Navin Kapur, MD Associate Professor, Department of Medicine, Interventional, Cardiology and Advanced Heart Failure Programs, Tufts Medical Center Learning Objectives Learn about the different modalities of devices for heart failure Learn about the elements for a successful translational program Understand the hemodynamics of heart failure Understand the interaction of pre-clinical and clinical development
Current Landscape and Future Direction – Intracardiac Shunts and Ventricular Remodeling Therapies
Gregg Stone, MD Professor of Medicine, Columbia University Learning Objectives Understand the different types of inter-atrial shunts Learn about the different devices currently available Understand the mechanism of shunts in potential improvement of heart failure Learn about the future technology and devices for the treatment of heart failure