New Cypher PMA filed
This article was originally published in The Gray Sheet
Executive Summary
Johnson & Johnson/Cordis filed for an in-stent restenosis indication for the sirolimus-eluting stent, firm announces May 11. Data from the 384-patient SISR trial showed that patients with blockage in previously implanted bare-metal stents who received Cypher stents had a lower incidence of target vessel failure than patients who underwent brachytherapy. Brachytherapy, or radiation from within the vessel, is the only FDA-approved treatment for in-stent restenosis. Competitor Boston Scientific's Taxus paclitaxel-eluting stent also showed positive results for the indication in the Taxus V clinical trial (1"The Gray Sheet" March 20, 2006, p. 6)...