Panel backs drug-coated stents: FDA spokeswoman
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GAITHERSBURG, Maryland  - A U.S. advisory panel unanimously said the benefits of drug-coated heart stents outweigh their risks when used as directed, a Food and Drug Administration spokeswoman said on Thursday.
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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 flurry of recent research has raised alarm about the safety of a new generation of stents that have quickly become the most commonly used devices for treating clogged arteries, creating widespread concern about how to care for millions of heart-disease patients.
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A U.S. advisory panel on Friday urged regulators to reject over-the-counter sales of Merck & Co. Inc.'s  cholesterol-lowering drug Mevacor.
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Kaiser Permanente, one of the biggest   U.S. health and hospital systems, has begun to study the safety   of drug-coated stents amid new signals that the widely used   heart devices might lead to fatal blood clots.
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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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The catheter that triggered three safety recalls by Boston Scientific Corp. of its best-selling Taxus coronary stent after being linked to three deaths and 47 injuries had not been subjected to the rigors of a human clinical trial, FDA records show.
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Coronary stents don&#39;t improve the long-term survival rates of heart patients, a Duke University Medical Center study contends.
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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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U.S. health regulators on Friday approved Medtronic Inc's new drug-eluting heart stent, the first heart device of its kind to win U.S. approval in about 4 years.
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As part of a federal inquiry into drug and medical-device marketing, Boston Scientific Corp. was asked by Congress last week to submit to investigators internal documents, marketing plans, and clinical data related to its top-selling product, the Taxus drug-coated stent.
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The panel will weigh evidence that stents used to treat clogged arteries can cause fatal blood clots, and is expected to recommend stricter regulation of the devices.
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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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Blood clotting is four to five times more likely to occur in patients who have drug-coated heart devices known as stents, compared with the older bare-metal variety, according to a large data analysis by the Cleveland Clinic released yesterday.
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Some cardiologists suggest drug-coated stents carry a higher risk of potentially fatal blood clots than older, bare-metal stents.
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VANCOUVER (CP) - Angiotech Pharmaceuticals Inc. says the European Patent Office has maintained the validity of Angiotech's patent on specially coated medical stents.
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The concerns that have been raised about the safety of drug-eluting stents at a major cardiology conference shouldn't mean it's time to go back to older treatments, the chief medical and scientific officer of Natick medical technology company Boston Scientific Corp. said yesterday.