Conor predicts early 2007 US filing for CoStar drug-eluting stent:
This article was originally published in Clinica
Executive Summary
Conor Medsystems believes it could be set to submit a US marketing application for its CoStar drug-eluting stent early next year, pending favourable results from a pivotal trial of the device, which was recently reported to have enrolled all of its 1,700 assigned patients. The COSTAR II trial is comparing Conor's cobalt chromium paclitaxel-eluting stent with Boston Scientific's paclitaxel-eluting Taxus Express2 stent in de novo lesions in patients with single or multi-vessel coronary artery disease. The Menlo Park, California firm believes that an early 2007 PMA submission for CoStar could put it in line for receiving FDA approval in late 2007 or early 2008. CoStar was CE-marked earlier this year and is currently being marketed in certain countries in Europe, Latin America and Asia.