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 panel meeting in April, although they were not voting members.
Gallagher AG, Cates CU. Virtual Reality Training for Carotid Stenting—Reply. JAMA. 2005;293(17):2091–2092. doi:10.1001/jama.293.17.2091-b
Customize your JAMA Network experience by selecting one or more topics from the list below.