Safety of Drug-Coated Stents Tough to Assess, Report Says
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The New England Journal of Medicine addresses the controversy about the potential for deadly clots.
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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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Expensive drug-coated stents -- used to prop open clogged coronary arteries -- are not worth using in many patients, Swiss researchers said on Friday.
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A flurry of recent research has raised alarm about the safety of a new generation of stents that have quickly become the most commonly used devices for treating clogged arteries, creating widespread concern about how to care for millions of heart-disease patients.
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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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WASHINGTON -- The Food and Drug Administration plans to revamp how it handles safety issues with the stents, pacemakers, implantable defibrillators and other medical devices it regulates.
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NEW YORK  - When people with diabetes  undergo coronary artery stenting to open clogs, women are more  at risk for major adverse events than men, doctors in Germany  report.
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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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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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Drug-coated heart stents on the U.S. market are associated with a small but significant risk of blood clots months after they are implanted, U.S. Food and Drug Administration staff said in documents released on Tuesday.
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Drug-eluting stents are safe and   effective for use in patients who had severe heart attacks, but   the potential risk of blood clots needed more study before the   devices could be recommended for all heart attack patients,   according to an editorial in a major medical journal.
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Less than a week after two sets of new data raised questions about the cardiovascular safety of two widely used painkillers, the Pfizer Inc.
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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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New drug-oozing stents widely used to prop open clogged arteries are associated with an increased risk of blood clots, heart attacks and death for the majority of patients receiving the devices, an expert panel concluded yesterday.
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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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VANCOUVER (CP) - Angiotech Pharmaceuticals Inc. says the European Patent Office has maintained the validity of Angiotech's patent on specially coated medical stents.
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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.