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Embolic protection device guidance

This article was originally published in The Gray Sheet

Executive Summary

Animal and bench testing is generally not adequate to support 510(k) clearance of coronary and carotid embolic protection devices, FDA says in a guidance document released Feb. 15. Clinical trials for the devices, which act as filters to capture and remove debris loosened during angioplasty or stenting, should be randomized unless an appropriate historical control can be identified for a single-arm study, the agency notes. Carotid embolic protection devices can generally be studied in conjunction with investigational carotid stent systems. FDA recommends a primary trial endpoint of all major adverse cardiac events, plus cerebrovascular events for carotid systems, at 30 days post procedure. An editorial in the Feb. 12 issue of Circulation from CDRH staffers suggests that single-arm studies for coronary embolic protection devices, used during intervention in diseased saphenous vein grafts, could be facilitated by further collaboration between industry, academia and regulators to develop benchmarks using data from previous trials

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