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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WASHINGTON -- The Food and Drug Administration plans to revamp how it handles safety issues with the stents, pacemakers, implantable defibrillators and other medical devices it regulates.
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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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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. 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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Johnson &amp; Johnson will delay by five months the release of a study comparing its Cypher heart device with Boston Scientific Corp.'s Taxus, the first large-scale comparison of the only two drug-coated stents on the market.
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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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The anticipated merger of Guidant Corp. and Johnson &amp; Johnson could give an unintended boost to Boston Scientific Corp. if Guidant's drug-coated stent launch is delayed, said analysts looking at the implications of a potential deal.
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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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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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Shares of Boston Scientific Corp. (BSX.N: Quote, Profile, Research) slid more than 3 percent in premarket trading on Wednesday after reporting that sales of its Taxus stent slowed
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GAITHERSBURG, Maryland  - The Food and Drug Administration should consider telling patients and doctors that the use of drug-coated heart stents in unapproved, high-risk cases can lead to greater complications, a panel of medical experts said on Friday.
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NATICK, Mass. - Boston Scientific Corp. violated its agreement with an Israeli company and acted in &quot;bad faith&quot; when it set up a secret stent-making operation in Ireland, according to a federal judge who ordered the companies to reach a settlement.
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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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Metronic joins the U.S. drug-eluting stent market.
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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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VIENNA - Boston Scientific Corp. yesterday said its Taxus Liberte drug-coated stent has shown positive one-year safety data in over 7,000 patients.