Carotid stent offerings grow
This article was originally published in The Gray Sheet
Executive Summary
Johnson & Johnson/Cordis receives PMA approval for its Precise carotid stent with the AngioGuard embolic protection system, joining Abbott in the U.S. market. Cordis will launch Precise nationwide in about two weeks, the firm said Sept. 26. It will market the product using data from SAPPHIRE, the only randomized controlled trial comparing carotid stenting to endarterectomy. A 2004 FDA corporate warning letter delayed the application for years, but a recent inspection at a Cordis facility in Florida with no adverse observations allowed it to proceed, according to Cordis (1"The Gray Sheet" Sept. 11, 2006, p. 6). Meanwhile, Medtronic filed the first of three PMA modules in early September for its Exponent carotid stent with the GuardWire system with an eye on late 2007 approval. Boston Scientific hopes to get approval for the Carotid WallStent Monorail carotid stent and FilterWire in early 2007...