FDA to Inspect Boston Scientific Stent Plant -WSJ
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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. 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 Food and Drug Administration is unlikely to sanction Boston Scientific Corp. after reviewing its handling of safety recalls of its new cardiac stent system, an agency official said yesterday.
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Boston Scientific announced 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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The US Food and Drug Administration (news - web sites) on Friday asked an outside group to review the way the agency monitors safety risks of medicines after they hit the market, such as Merck &amp; Co.
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Drug-coated stents may carry a delayed risk of potentially dangerous blood clots, according to a new report.
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Boston Scientific Corp. (BSX.N: Quote, Profile, Research) said on Wednesday that inspectors from the US Food and Drug Administration found no problems at a plant in Ireland that
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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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Boston Scientific Corp. , saddled with debt and a depressed share price since buying Guidant Corp., said on Monday it may sell a minority stake in its endosurgery business for more than $1 billion in a public offering.
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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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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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NEW YORK - Johnson &amp; Johnson and Boston Scientific Corp. reported new safety data yesterday for drug-coated stents that may help revive sales depressed by prior reports linking the devices to a higher risk of heart attacks.
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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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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. 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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Johnson &amp; Johnson's drug-coated Cypher heart stent may be better than Boston Scientific's Taxus for repeat procedures to unclog some arteries, according to a study in the Jan. 12 Journal of the American Medical Association.
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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.