Safety of Drug-Coated Stents Tough to Assess, Report Says
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The New England Journal of Medicine addresses the controversy about the potential for deadly clots.
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Meta-analysis finds J&J's stents are safer than Boston Scientific's stents -- maybe.
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VIENNA - Boston Scientific Corp. yesterday said its Taxus Liberte drug-coated stent has shown positive one-year safety data in over 7,000 patients.
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Drug-coated stents -- tiny wire-mesh tubes used to prop open clogged heart arteries -- may not be as dangerous as earlier thought, Swedish researchers who had raised concerns over the devices said on Sunday.
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The booming market for drug-coated   stents faces an uncertain future as some heart experts question   the long-term safety record of the devices.
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Last Thursday, the day the Food and Drug Administration launched a two-day advisory panel on the risks of drug-coated stents, doctors across the country found an e-mail on their computers from stent maker Johnson &amp; Johnson, inviting them to join a conference call about stent safety.
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Doctors can safely use drug-coated stents to open up complicated blockages in coronary arteries for which the devices were not originally designed, according to new research. In fact, they appear to work better than older, bare-metal stents in those situations.
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GAITHERSBURG, Maryland  - A U.S. advisory panel on Friday was divided over whether current data warrant changes to drug-coated heart stent labels for their use in patients with more medical complications unapproved for the device.
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WASHINGTON -- The Food and Drug Administration plans to revamp how it handles safety issues with the stents, pacemakers, implantable defibrillators and other medical devices it regulates.
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Bypass surgery remains the best option for heart patients with more than one clogged artery, according to the first big study to compare bypasses with drug-coated stents. In the study, heart attack and death rates were lower among people who had surgery than those given artery-opening balloon angioplasty and stents. It is latest setback for drug-coated stents, which have revolutionized heart care and have been implanted in about six million people worldwide. The study is in Thursdayâs New England Journal of Medicine.
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GAITHERSBURG, Maryland  - A U.S. advisory panel began hearing evidence on Thursday about potential risks of drug-coated stents, the tiny tubes used to prop open arteries in millions of heart patients.
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NEW YORK -- Results of a Korean study released yesterday show Cordis Corp.'s Cypher drug-coated stent outperformed Boston Scientific Corp.'s Taxus Express2 stent in a multicenter study.
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Drug-coated stents were linked to a higher death rate when given to people with a certain type of heart attack, a finding that may limit doctors' use of the mesh tubes to prop open arteries.
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Patients given drug-coated stents after an acute heart attack are nearly five times more likely to die six months to two years later than those with bare metal forms of the arterial scaffolding, research showed on Tuesday.
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Boston Scientific Corp. BSX.N on   Thursday said an internal analysis confirmed an increased risk   of blood clots with its drug-coated device used to keep   previously clogged arteries open.
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The most exhaustive studies yet published on drug-coated stents show that the widely used heart devices are no better at preventing heart attacks and death than the older, cheaper devices they replaced, and in some cases may be slightly worse.
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WASHINGTON -- Federal health officials asked experts Thursday whether the drug-coated stents used to prop open the arteries of about 3 million people in the U.S. pose a heightened risk of death or raise other safety concerns that require action.