J&J Recalling 300 Cypher Stents
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Johnson &amp; Johnson has announced a voluntary recall of one lot of its Cypher drug eluting stents because it noticed that six stents in the lot didn't have enough polymer coating on them.
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The medical device maker reported a third-quarter loss of $272 million on charges related to acquisitions and asset sales, as the companyâs top-selling stent continued to slump.
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Johnson &amp; Johnson's neck stent is as effective as surgery in clearing blocked blood vessels to the brain that can cause strokes and death, according to a company-funded study in tomorrow's New England Journal of Medicine.
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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.
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WASHINGTON -- Federal health officials asked experts Thursday whether the drug-coated stents used to prop open the arteries of about 3 million people in the U.S. pose a heightened risk of death or raise other safety concerns that require action.
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The U.S. Food and Drug Administration is planning to release new testing requirements for drug-coated heart stents in the next few weeks, the regulatory agency's device chief, Daniel Schultz, told the Wall Street Journal.
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MONDAY, Dec. 4 (HealthDay News) -- Heart patients with drug-eluting stents implanted to keep their arteries open were found to have a much higher risk of sudden death than those getting bare metal stents if they stopped taking the blood thinner Plavix, a new Swiss study reports.
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Meta-analysis finds J&J's stents are safer than Boston Scientific's stents -- maybe.
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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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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. 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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A Food and Drug Administration panel tomorrow will consider one of the most urgent questions in medicine: what to do about the risk of blood clots caused by drug-coated stents, tiny medical devices implanted in the arteries of millions of people.
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The new drug-coated stents implanted to keep arteries open might increase the risk of a later heart attack if a patient stops taking clot-preventing drugs such as aspirin even briefly, Dutch cardiologists warn.
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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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Drug-coated stents may carry a delayed risk of potentially dangerous blood clots, according to a new report.
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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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Growing evidence that deadly clots can form in drug-coated stents does not mean that the risks of using the devices the benefits, according to a panel of experts.