Boston Scientific Corp. Receives FDA Approval For Drug-Eluting Coronary Stent Use In Heart Attack Patients

Boston Scientific Corp. announced that ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System and TAXUS Liberte Paclitaxel-Eluting Coronary Stent System have received U.S. Food and Drug Administration (FDA) approval for use in patients experiencing an acute myocardial infarction (AMI), or heart attack. They are the only drug-eluting stent (DES) systems in the U.S. with an approved indication to treat patients with AMI. The new indication, which accounts for approximately 10% 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.