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FDA mulls Boston Scientific stent snag

WASHINGTON, Nov. 14 (UPI) -- The Food and Drug Administration is reportedly reviewing a case where a Michigan hospital temporarily halted use of Boston Scientific's Taxus cardiac stents.

The FDA probe stems from incidents in late September and early October in which Royal Oak, Mich.-based William Beaumont Hospital suspended for two weeks use of the medical devices after two patients sustained arterial injuries, according to a report published Monday in the Wall Street Journal.

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In both cases the lead wires used to place the stent in the patient's artery became lodged in the artery, causing injury.

Although the hospital resumed use of the stents, a Beaumont doctor alerted the FDA to a possible safety issue and accused Natick, Mass.-based Boston Scientific of mischaracterizing the incident, the report said.

The U.S. cardiac stent market is comprised of approximately 1.5 million patients annually, with market share roughly split between Boston Scientific and Johnson & Johnson, based in New Brunswick, N.J., the report said.

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