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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

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