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Conor Medsystems, LLC Reports COSTAR II Pivotal Drug-Eluting Stent,Trial Conclusions

MENLO PARK, Calif., May 07, 2007 /PRNewswire-FirstCall/ -- Citing issues related to potentially sub-optimal therapeutic dosing of paclitaxel, Conor Medsystems, LLC has concluded that the COSTAR II (CObalt Chromium STent with Antiproliferative for Restenosis) trial, the pivotal study for the CoStar cobalt chromium paclitaxel-eluting coronary stent, failed to meet its primary endpoint. The trial did not identify safety issues, and the overall rates of death, myocardial infarction and stent thrombosis were consistent with those observed in other clinically relevant drug-eluting stent studies.

As a result of these outcomes, the company will terminate ongoing clinical trials with the CoStar(R) stent and will not conclude the submission of its Pre-Market Approval application to the U.S. Food and Drug Administration for the product. Further, Conor Medsystems will discontinue sale of the product through commercial partners in certain countries in Europe, Asia and Latin America where the CoStar stent is already approved, and will work with those partners to facilitate return of product in inventory in customer accounts.

The COSTAR II trial compared the CoStar(R) stent with the Taxus Express(2) paclitaxel drug-eluting stent, and was designed to demonstrate non-inferiority at eight-month follow-up with respect to major adverse cardiac events (MACE) in patients with multi-vessel or single-vessel disease. In this trial, MACE was defined as a composite of clinically driven target vessel revascularization, heart attack (new myocardial infarction) related to the target vessel and cardiac death related to an intervened vessel.

"While we are disappointed in these results, we remain optimistic about the ability of the novel Conor Medsystems reservoir platform to provide precise and controlled delivery of a therapeutic agent based on earlier proof of concept testing and trials," said Campbell Rogers, M.D., chi
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