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Introduction to the Cardiac Cath Lab

Morton Kern, MD Chief of Medicine, VA Long Beach Professor of Medicine, University of California Irvine Learning Objectives What is involved with Cardiac Cath When is it indicated or contraindicated What are the anticipated results What common therapeutic procedures are available to the patient in the cath lab

Lecture – Renu Virmani, MD, CV Path Institute

Renu Virmani, MD President, CV Path Institute Learning Objectives Understand the differences between animal model and human Learn the evaluation of the safety endpoints for decides in animal model Learn the timeline of histological evaluation and the method of evaluation Learn which animal model to use for what device Recognize the importance of different endpoints […]

Lecture – Judith Davis, DVM, MS, FDA

Judith Davis, DVM, MS Senior Veterinary Medicine Reviewer, Cardiac Electrophysiology Devices Branch, FDA Learning Objectives Understand the risk assessment and mitigation of risk Learn how to plan and design animal study Understand the meaning of device performance and handling Learn the importance of early discussion with regulatory as early as possible Learn when animal study […]

Lecture – Daniel Burkhoff, MD, Colombia University

Daniel Burkhoff, MD, PhD Adjunct Associate Professor of Medicine, Columbia University Learning Objectives Learn the device cycle development Understand the advantages and limitations of animal models Understand the important differences between different animals, small and large Understand the differences between animal model an a human anatomy and disease