FDA to Inspect Boston Scientific Stent Plant -WSJ
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The U.S. Food and Drug Administration  expects to inspect Boston Scientific Corp.'s Galway, Ireland  factory in the "near future" as part of its probe into the  company's coronary stent recall, the Wall Street Journal said  on Friday.
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Johnson &amp; Johnson can't supply cardiac stents fast enough to capitalize on three recent recalls by archrival Boston Scientific Corp. , say cardiologists who use both companies' medical devices.
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Meta-analysis finds J&J's stents are safer than Boston Scientific's stents -- maybe.
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Boston Scientific Corp. shipped millions of dollars worth of coronary stents in fall 1998 even after company officials learned that the medical devices had high failure rates and may not have met specifications approved by the Food and Drug Administration.
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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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Boston Scientific Corp. (BSX.N: Quote, Profile, Research) said on Wednesday it received US regulatory approval for a device to treat complications that arise in patients with end-stage kidney disease who need dialysis.
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GAITHERSBURG, Maryland  - A U.S. advisory panel heard evidence on Thursday about risks of drug-coated stents, the tiny mesh tubes used to prop open arteries in millions of heart patients.
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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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Boston Scientific Corp. (BSX.N: Quote, Profile, Research) said on Wednesday it already recovered market share for its popular heart device after a recent recall
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Boston Scientific receives a warning letter from the FDA on a discontinued stent trial.
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Abbott Laboratories Inc.  on Friday said it submitted its application to the U.S. Food and Drug Administration for its drug-coated stent called Xience and expects to start selling the heart device in the first half of 2008.
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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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Boston Scientific Corp. has introduced the Taxus Liberte coronary stent, the second generation of its market-leading product, to 18 countries in Asia, Africa, and South America. The Natick company expects to launch the product in Europe this year. In the United States, the product is in the clinical-trial phase of regulatory approval.
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Boston Scientific Corp. stock rose more than 5 per cent Wednesday after company executives called a recent recall of its Taxus heart stents a blip and said most of the lost market share has already been recovered.
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Boston Scientific Corp.  posted a lower-than-expected quarterly profit on Friday as sales of its flagship drug-eluting heart stents fell by 32 percent.
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Boston Scientific Corp. found a slightly higher risk of blood clotting in patients implanted with its newer drug-coated stents compared with older bare-metal versions, a company spokesman said Thursday.
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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.