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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Boston Scientific Corp. said yesterday it sold $8.3 million worth of its Taxus drug-coated cardiac stents per day this month, a record level the Natick medical
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The US Food and Drug Administration expects to inspect Boston Scientific Corp.&#39;s Galway, Ireland factory in the &quot;near future&quot; as part of its probe into the company&#39;s coronary stent recall, the Wall Street Journal said on Friday.
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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 announces an investment in Â and strategic partnership with Â REVA Medical, which is working on a polymer successor to todayÂs metal stents that would be biodegradable in the body.
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BARCELONA -- Specialists expressed concerns yesterday that drug-coated heart stents -- metal-mesh tubes used to prop open coronary arteries -- might increase the chances of potentially fatal blood clots.
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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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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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Boston Scientific Corp. may forecast a drop in third-quarter sales of its Taxus heart stent after three recalls cut demand for the device, the company's top-selling product.
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Drug-coated heart stents on the U.S. market are associated with a small but significant risk of blood clots months after they are implanted, U.S. Food and Drug Administration staff said in documents released on Tuesday.
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GAITHERSBURG, Maryland  - The broad use of drug-coated heart stents in unapproved patients came under scrutiny on Friday as U.S. advisers weighed the risks of the tiny tubes implanted in millions to keep arteries open.
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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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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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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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Boston Scientific Corp. said yesterday it has won back the market share that its flagship cardiac stent system held before three safety recalls reduced doctors' orders of the product.
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Boston Scientific Corp. said Monday that it received Food and Drug Administration clearance to market a device designed to lower the risk of heart attacks during angioplasty and stenting procedures.
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Boston Scientific Corp.  posted a lower-than-expected quarterly profit on Friday as sales of its flagship drug-eluting heart stent fell by 32 percent.