May 7, 2007 — Citing issues related to potentially suboptimal 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(R) 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 stent and will not conclude the submission of its PreMarket Approval application to the FDA for the product. Further, Conor Medsystems says it 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 noninferiority at eight-month follow-up with respect to major adverse cardiac events (MACE) in patients with multivessel 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.
Conor Medsystems, LLC, a wholly-owned subsidiary of Johnson & Johnson, develops innovative controlled vascular drug delivery technologies and has primarily focused on the development of drug-eluting stents to treat coronary artery disease.
For more information www.conormed.com.