A Range of Changes for Stent Makers
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The FDA is about to make it harder for drug-eluting stents to win its approval.
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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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Last Thursday, the day the Food and Drug Administration launched a two-day advisory panel on the risks of drug-coated stents, doctors across the country found an e-mail on their computers from stent maker Johnson &amp; Johnson, inviting them to join a conference call about stent safety.
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In light of new concerns over stentsâ risks, surgery may be poised for a comeback for treating plaque-clogged arteries.
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The concerns that have been raised about the safety of drug-eluting stents at a major cardiology conference shouldn't mean it's time to go back to older treatments, the chief medical and scientific officer of Natick medical technology company Boston Scientific Corp. said yesterday.
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A panel of experts reaches mixed conclusions on the safety and effectiveness of drug-coated stents.
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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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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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Nov. 8, 2004 -- Stents cut a patient&#39;s risk of having a repeat balloon angioplasty to clear a clogged artery. But patients who get stents don&#39;t survive any longer than those who don&#39;t get them.
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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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The three recalls of Boston Scientific Corp. cardiac stents since July 2 affected many more units than the company has previously disclosed, raising concerns among stock analysts about future inventory levels.
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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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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 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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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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The nationâs two leading heart groups issued new guidelines Thursday about what should be done for patients with heart disease before they undergo surgery on other parts of the body.
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The Natick medical devices company is using profits from its successful Taxus stent to expand into new areas. By Ross Kerber, Globe Staff | December 6, 2004.