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US Medicare to Reimburse for Carotid Stent Use
Reuters
October 13, 2004
The agency that runs the government insurance program also said it would reimburse use of the device in post-approval studies required by the U.S. Food and Drug Administration.
Doctors implant a stent, a tiny tube, by threading it through a small incision in the groin and guiding it through blood vessels to the neck to prop open the carotid artery.
The devices aim to prevent the buildup of fatty deposits that can break off and travel to the brain, where they can cause strokes.
The FDA approved Guidant Corp.'s carotid artery stent in August, making it the first of its kind to prevent stroke, the third-leading cause of death in the United States.
Johnson & Johnson is awaiting final FDA approval of its carotid stent. Boston Scientific Corp., Medtronic Corp. and Abbott Laboratories Inc. also are working on similar devices.
Centers for Medicare and Medicaid Services officials said the decision, which was made shortly after a mandatory public comment period but before the end of the agency's two-month review time, was part of an effort to make coverage decisions more quickly.
CMS first said it supported expanding its coverage of the device in September, one day after Guidant's approval. The agency announced its final ruling on Tuesday.
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