Drug-coated heart stents face safety review
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U.S. advisers will start considering on Thursday the risks of drug-coated stents implanted in millions of heart patients, examining evidence showing the devices may lead to dangerous blood clots.
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Blood clotting is four to five times more likely to occur in patients who have drug-coated heart devices known as stents, compared with the older bare-metal variety, according to a large data analysis by the Cleveland Clinic released yesterday.
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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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The Food and Drug Administration said last night it would convene a public panel to examine the risk of blood clots in patients with drug-coated stents, among the world's most frequently implanted medical devices.
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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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A new type of heart "stent" has been developed to unblock diseased arteries and then dissolve without a trace.
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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. 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 panel recommended that doctors and patients be given stronger warnings about the dangers associated with the use of drug-coated stents.
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Blood clotting is four to five times more likely to occur in patients getting drug-coated heart devices known as stents, compared to the older bare-metal variety, according to a large data analysis released on Wednesday.
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GAITHERSBURG, Maryland  - A U.S. advisory panel unanimously said the benefits of drug-coated heart stents outweigh their risks when used as directed, a Food and Drug Administration spokeswoman said on Thursday.
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Even some heart attack patients would be better off if their doctors avoided using drug-coated stents to open their clogged arteries, an international study found, raising new concerns about the devices.
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In light of new concerns over stentsâ risks, surgery may be poised for a comeback for treating plaque-clogged arteries.
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Patients given drug-coated stents after an acute heart attack are nearly 5 percent more likely to die a year or more later than those with bare metal forms of the arterial scaffolding, new research showed on Tuesday.
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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.
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Drug-coated stents are safe to implant in cardiac blood vessels immediately after a heart attack, according to two studies in today's New England Journal of Medicine.
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Doctors can safely use drug-coated stents to open up complicated blockages in coronary arteries for which the devices were not originally designed, according to new research. In fact, they appear to work better than older, bare-metal stents in those situations.