FDA seen toughening coated-stent requirements: WSJ
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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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The new heart stent from Medtronic Inc. has been assocated with more blood clots than a rival product has, federal regulators have concluded.
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The two manufacturers of drug-coated stents used to prop open the arteries of about 3 million people in the U.S. say the devices' benefits outweigh their risks, even though patients could face a small but significant risk of blood clots.
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GAITHERSBURG, Maryland  - The broad use of drug-coated heart stents in unapproved patients came under scrutiny on Friday as U.S. advisers weighed the risks of the tiny tubes implanted in millions to keep arteries open.
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Boston Scientific Corp. , of Natick, is seeking to market its Taxus heart stent to diabetics in the United States, who make up one-third of all stent patients. Taxus shows signs of being at least as effective and safe in diabetics as the rival Cypher stent, made by Johnson &amp; Johnson, Donald Baim, chief scientific officer at Boston ...
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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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Boston Scientific Corp. shipped millions of dollars worth of coronary stents in fall 1998 even after company officials learned that the medical devices had
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Drug-coated heart stents might not increase the risk of blood clots as much as previously thought, according to research presented Sunday at a meeting of cardiologists.
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Results of a study showing patients with acute heart attacks are more likely to die if given a drug-coated stent than a bare metal one are out of line with other findings, stent maker Johnson & Johnson said on Tuesday.
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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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The most exhaustive studies yet published on drug-coated stents show that the widely used heart devices are no better at preventing heart attacks and death than the older, cheaper devices they replaced, and in some cases may be slightly worse.
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New drug-releasing stents used widely to keep clogged heart arteries open appear to increase the risk for potentially life-threatening blood clots more than older bare-metal versions, government investigators told an expert panel assessing the safety of the devices today.
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Drug-coated heart stents may not increase the risk of blood clots as much as previously thought, according to research presented Sunday at a meeting of cardiologists.
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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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Federal advisers heard conflicting data today about the safety of new drug-oozing stents used to keep clogged arteries open as the experts struggled to advise government regulators about whether the risks of the devices outweigh their benefits for millions of patients.
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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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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.