Interventional cardiology live case presentations: regulatory considerations

• Published in: Journal of the American College of Cardiology Vol. 56; no. 15; p. 1283
• Main Authors: Farb, Andrew, Brown, Sheila A, Wolf, Deborah A, Zuckerman, Bram
• Format: Journal Article
• Language: English
• Published: United States Elsevier Limited 05.10.2010
• Subjects: Cardiology; Cardiology - legislation & jurisprudence; Cardiology - standards; Device Approval - legislation & jurisprudence; Device Approval - standards; FDA approval; Hospitals; Humans; Medical equipment; Patient safety; Pharmaceutical industry; Remote Consultation - legislation & jurisprudence; Remote Consultation - standards; Therapies, Investigational - standards; United States; United States; United States > US
• ISSN: 0735-1097; 1558-3597; 1558-3597
• DOI: 10.1016/j.jacc.2010.08.601

In the context of an unapproved device being used in an IDE study, FDA defines a live case presentation as: "Treatment of a human subject under the auspices of an approved or conditionally approved IDE, conducted and broadcast in real time, or recorded and broadcast at a later time, to an audience at a widely attended professional scientific meeting." Since investigational devices are not available for use outside of an IDE study (and might not ever become available in the U.S. if the device does not ultimately receive FDA approval or clearance), the Agency's view is that the use of an unapproved device in live case demonstrations should be limited to providing increased awareness of the IDE study for potential investigators and practicing physicians to augment the recruitment of study subjects. [...]as there have been few studies of adverse events or outcomes related to live cases (3,4), more research on procedural safety outcomes during live case presentations is needed to better define patient risks, particularly at a time in which live case presentations have become a cornerstone of many interventional cardiology meetings.