Six on FDA stent panel have ties to device firms
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Six physicians with financial ties to Johnson &amp; Johnson and other heart-device makers will be advising US regulators whether to restrict the use of some products because of potentially lethal side effects.
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Boston Scientific Corp. has introduced the Taxus Liberte coronary stent, the second generation of its market-leading product, to 18 countries in Asia, Africa, and South America. The Natick company expects to launch the product in Europe this year. In the United States, the product is in the clinical-trial phase of regulatory approval.
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Boston Scientific Corp. wants investors to look beyond its cardiac stents. The tiny wire-mesh tubes have become the hottest-selling medical device in Boston Scientific's history, and were the main reason the Natick company yesterday reported its fourth-quarter profit more than doubled.
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Boston Scientific Corp. and Medtronic Inc. , competing to enter the US market for stents that keep neck arteries open, said separate studies showed their devices prevent complications including stroke after 30 days.
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NEW YORK - Johnson &amp; Johnson and Boston Scientific Corp. reported new safety data yesterday for drug-coated stents that may help revive sales depressed by prior reports linking the devices to a higher risk of heart attacks.
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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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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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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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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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Boston Scientific Corp. said Monday that it received Food and Drug Administration clearance to market a device designed to lower the risk of heart attacks during angioplasty and stenting procedures.
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Drug-coated stents -- tiny, wire-mesh   tubes used to prop open diseased arteries -- may increase the   risk of potentially fatal blood clots, researchers said on   Sunday.
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Abbott Laboratories and Medtronic Inc. are poised to seize a third of the $5 billion in annual heart-stent sales with new versions of the drug-coated devices.
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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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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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Edward M. Rudnic, chairman of the Tech Council of Maryland, has been at the center of the region's biotech business for more than a decade. He sketched out the idea behind MiddleBrook Pharmaceuticals at a friend's dining-room table. If there is a biotech event around town, he's probably speaking or...
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Johnson &amp; Johnson and Boston Scientific, the top makers of drug-coated heart stents, both released studies saying their $2,200 devices are safer than bare-metal stents that cost half as much. The studies capped three days of debate at Europe's biggest medical conference, the World Cardiology Congress in Barcelona, sparked by independent researchers who said bare-metal stents were safer. The Boston ...
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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.