FDA to study the risks of coated stents
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Millions of chest pain and heart attack sufferers thought they were getting a phenomenal medical advance when tiny coils that ooze medicine were placed in their arteries to keep them from squeezing shut again.
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Boston Scientific Corp. shipped millions of dollars worth of coronary stents in fall 1998 even after company officials learned that the medical devices had high failure rates and may not have met specifications approved by the Food and Drug Administration.
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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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Boston Scientific receives a warning letter from the FDA on a discontinued stent trial.
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Experts expressed concerns Sunday that drug-coated heart stents &#151; metal-mesh tubes used to prop open coronary arteries &#151; may in rare instances lead to potentially fatal blood clots.
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Drug-releasing stents used widely to keep clogged heart arteries open may increase the risk of potentially dangerous blood clots, but there is no conclusive evidence that the devices boost the likelihood of having a heart attack or dying if used as recommended, an expert panel said yesterday.
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Stent makers and cardiologists said reports at this yearâs major meeting of European cardiologists bolstered their confidence in the safety of the newer drug-coated versions of the devices.
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GAITHERSBURG, Maryland  - Drug-coated heart stents deliver benefits that outweigh any risks of blood clots when used as directed, a U.S. advisory panel said on Thursday.
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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 FDA is about to make it harder for drug-eluting stents to win its approval.
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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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Johnson &amp; Johnson is picking a price fight over drug-coated stents. Does Boston Scientific Corp. need to respond?
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Patients implanted with drug-coated stents to hold open their choked arteries face a small but significant risk of blood clots, health officials said Tuesday, and a new study recommended they take clot-busting medications indefinitely.
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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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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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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.
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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.