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Second
Generation Conor CoStar Drug-Eluting Stent Data to be Announced
at EuroPCR |
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| February 23, 2007 -- Conor Medsystems, recently acquired by Johnson & Johnson, plans to present data from its pivotal COSTAR II clinical trial at the annual EuroPCR meeting in May. The COSTAR II, which enrolled 1,700 patients at over 70 sites, compares the Conor CoStar, a second generation drug-eluting stent, with the first generation Taxus, manufactured by Boston Scientific. Both use the same drug, but they deliver the drug in very different ways. The CoStar is currently approved and sold in Europe. The COSTAR II trial will be a study that the FDA will use in determining whether to approve the Conor stent for use in the United States. The CoStar stent is designed with tiny laser-cut dimples, or reservoirs, in the stent surface. These reservoirs are then filled with a bioabsorable polymer that elutes the drug paclitaxel, which prevents restenosis. After six months, not only has the drug completely been eluted but the polymer itself has been completely bioabsorbed, leaving in the artery what is in effect a bare metal stent. The concept of the CoStar is that its design will avoid the much-publicized problem of late stent thrombosis. The Taxus (as well as Johnson & Johnson's first generation Cypher stent) uses a permanent polymer coating -- it has been theorized that these polymers may be one of the causes of late stent thrombosis. The late stent thrombosis question may not be answered by the EuroPCR presentation which only tracks patients to eight or nine months (late stent thrombosis is defined as a blood clot which occurs anywhere from six months to three years or longer). However, all eyes will be on the Conor results, which may signal a new engagement in the ongoing "Stent Wars" between Boston Scientific and Johnson & Johnson. Additionally, clinical trials may not be the only trials surrounding the CoStar. Boston Scientific and its polymer supplier Angiotech (of Vancouver, Canada) have filed several lawsuits, aimed at preventing Conor from using paclitaxel as its antirestenosis drug. As to why the EuroPCR course was chosen as the presentation venue, Conor General Manager, Michael Boennighausen, stated, "The last patient was followed-up in February 2007, and we expect the independent clinical research organization (CRO) to commence the data analysis in March, providing sufficient time for presentation at the upcoming EuroPCR meeting." |
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