U.S. panel backs drug-coated stent use
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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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Blood clotting is four to five times more likely 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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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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GAITHERSBURG, Md. -- Drug-coated stents increase the risk of potentially fatal blood clots and heart attacks in some patients, but not enough to warrant limiting use of the devices, federal advisers said yesterday .
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GAITHERSBURG, Maryland  - Drug-coated heart stents are more likely to cause blood clots and other complications in certain high-risk cases and patients and doctors should be warned, a panel of medical experts advised on Friday.
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Johnson & Johnson's drug-coated stent slightly outperformed Boston Scientific's version in reopening arteries that had been clogged by lesions following the earlier insertion of bare-metal stents, a study said on Tuesday.
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FDA advisory panel gives the nod to its heart drug.
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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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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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Kaiser Permanente, one of the biggest   U.S. health and hospital systems, has begun to study the safety   of drug-coated stents amid new signals that the widely used   heart devices might lead to fatal blood clots.
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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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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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U.S. health regulators on Friday approved Medtronic Inc's new drug-eluting heart stent, the first heart device of its kind to win U.S. approval in about 4 years.
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The Food and Drug Administration (FDA) has approved a stent for use in opening blocked arteries in the neck. The new stent is intended to prevent stroke by treating blockages in the carotid artery, the main blood vessel leading to the brain.
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Johnson &amp; Johnson's drug-coated Cypher heart stent may be better than Boston Scientific's Taxus for repeat procedures to unclog some arteries, according to a study in the Jan. 12 Journal of the American Medical Association.
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The booming market for drug-coated   stents faces an uncertain future as some heart experts question   the long-term safety record of the devices.
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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.