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In Reply: Dr Hartman questions our statements about approval of the proposal by the FDA panel. At the April 2004 meeting, Cordis, the manufacturer of the stent, presented data from a prospective randomized trial of carotid stenting vs endarterectomy,¹ details of a postmarketing surveillance study the company intended to conduct as part of the introduction of the product into the marketplace, a training package the company planned to ensure the safe performance by physicians not experienced in carotid stenting, and the types of patients that should be included in the surveillance study. The FDA panel voted to approve this package in its entirety, and simulation training was an integral part of this package.² In addition, virtual reality simulation training was explained in considerable detail to the FDA at a closed-door meeting in March 2004, and senior members of the FDA who attended the March meeting officiated at the full FDA . . . [Full Text of this Article]

Anthony G. Gallagher, PhD; Christopher U. Cates, MD
christopher_cates@emoryhealthcare.org
Division of Cardiology
Department of Medicine
Emory University
Atlanta, Ga

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