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Home » Boston Scientific Stent Gets FDA Direction
Boston Scientific Stent Gets FDA Direction
April 7, 2005
Boston Scientific said that the FDA approved new directions for its Taxus Express2 drug-coated coronary stent, allowing doctors to perform magnetic resonance imaging (MRI) on a patient soon after receiving the device.
Before the approval, directions recommended that a doctor wait at least two months before performing an MRI on patients implanted with the stent. Due to the intense magnetic fields generated by an MRI machine, metal devices and implants in the body can potentially migrate or heat up.
Boston Scientific said the Taxus is the first drug-coated stent to receive approval for the amended directions. The new directions also apply to its non-drug-coated Taxus stent.
KEYWORDS FDAnews Device Daily Bulletin
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