FDA panel to examine drug-coated stents
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An outside panel of health experts will examine whether drug-coated stents used to prop open coronary arteries can produce sometimes fatal blood clots, the Food and Drug Administration said Thursday.
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A panel of experts reaches mixed conclusions on the safety and effectiveness of drug-coated stents.
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Boston Scientific Corp. yesterday revealed details about the experimental drug-coated stent it acquired when it bought Guidant Corp. this year. The device will be called Promus, and the Natick medical device maker expects to start selling it in 2008.
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U.S. regulators said on Friday they would review a study showing a Merck and Schering-Plough cholesterol drug worked no better than a generic in preventing the build-up of arterial plaque.
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U.S. regulators said on Friday they  would review a study showing a Merck and Schering-Plough  cholesterol drug worked no better than a generic in preventing  the build-up of arterial plaque.
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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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The FDA decides to debate the company's lead drug.
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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 Medicare program is rethinking its blanket coverage for all uses of drug-coated heart stents, a potential blow to Boston Scientific Corp. , Johnson &amp; Johnson, and others in the $6 billion-a-year industry.
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Drug-coated stents are safe to implant in cardiac blood vessels immediately after a heart attack, according to two studies in today's 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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A U.S. advisory panel on Friday will  review data on an experimental drug that is injected into the  eye to stop vision loss in elderly patients at risk of going  blind.
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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.
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A panel recommended that doctors and patients be given stronger warnings about the dangers associated with the use of drug-coated stents.
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A jury in Texas has ruled that Boston Scientificâs drug-coated stents infringe a 1997 patent issued to a radiologist in Princeton, N.J., and has awarded the inventor $431 million in damages, Boston Scientific said Tuesday. The suit by the patent holder, Dr. Bruce N. Saffran, did not seek to halt sales of the stents.
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GAITHERSBURG, Md. -- Federal advisers yesterday said that drug-coated stents, which have been implanted in millions, offer clear benefits to many patients but present higher clotting risks to others, suggesting they may be overused.
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Britain's medicines advisory agency is now planning to publish its latest recommendations on the cost-effectiveness of drug-coated stents late next week, in a decision that could draw fire from manufacturers.