Lydia Glaw, PhD Assistant Director, Coronary Interventional Devices Team, FDA Learning Objectives Understand the different type of complex lesions Recognize the device landscape Recognize the regulatory requirement for non-clinical testing Recognize the clinical data and the design of clinical trials required for FDA approval
Kevin Croce, MD, PhD Director, CTO & Complex Coronary Artery Intervention Program, Harvard Medical School Learning Objectives Learn about the animal model for pre-clinical testing Understand the steps for preclinical evaluation of atherectomy devices Learn the endpoint that one can obtain from animal testing Learn the different evidence that can be obtained from acute vs […]
Ajay Kirtane, MD Associate Professor of Medicine, Columbia University Medical Center Learning Objectives Recognize the importance of detecting calcification Recognize the feature of atherosclerotic plaque and the need for atherectomy Learn about the future clinical trials to deal with calcified stenosis Recognize the future need to managing complex coronary intervention
Shawn Forrest Team Lead, Blood Pressure and Flow Devices Office of Device Development, FDA Learning Objectives Understand the coronary assessment device classification Learn the meaning of too claim and diagnostic claim Learn the diagnostic clinical validation Learn the requirement of pre-submission for diagnostic devices
Robert Safian, MD Director, Center for Innovation & Research in Cardiovascular Diseases (CIRC) Learning Objectives Learn the history of development of coronary physiology assessment Understand the 3-D model to evaluate coronary flow and obstructive coronary artery disease Learn the potential of CT coronary angiography in characterizing atherosclerotic disease Learn the ability of CT to assess […]
Morton Kern, MD Chief of Medicine, VA Long Beach Professor of Medicine, University of California Irvine Learning Objectives Understand the lack of true gold standard for ischemia Learn the potential of IVUS, OCT, and NIR technology in identifying high-risk lesion Understand the method of OCT and polarization of tissue characterization Understand the hyperemic vs non […]
James Min, MD Professor of Radiology and Medicine, Weill Cornell Medicine Learning Objectives Learn that atherosclerosis burden predicts clinical outcome more than coronary stenosis Understand that atherosclerosis can discriminate high vs low-risk Learn the clinical risk of risk factors vs stenosis vs atherosclerosis
