By Professor Juan Tamargo, Madrid, Spain
The FDA approved the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System and TAXUS® Liberte® Paclitaxel-Eluting Coronary Stent Systems for use in patients experiencing an acute MI.
The FDA based its approval on a review of data from the Paclitaxel (Taxus) clinical program and HORIZONS-AMI trial enrolling 3,006 patients were randomly assigned to receive either either drug-eluting stents (DES) or bare-metal stents for the treatment of acute MI, thus being the largest randomized trial to study coronary stents in MI patients. Boston’s ION Stent System incorporates a unique platinum chromium (PtCr) alloy designed specifically for coronary stenting.
The new indication, which accounts for approximately 10 percent of all coronary interventions, is a result of FDA review of data from the Paclitaxel (TAXUS) clinical program and HORIZONS-AMI trial. In the global HORIZONS-AMI trial, 3,006 patients were randomized to receive either drug-eluting stents or bare-metal stents for the treatment of AMI, making it the largest randomized trial to study coronary stents in heart attack patients.