FDA approves ION and TAXUS Liberte Drug-Eluting Coronary Stents (Boston Scientific) in Heart Attack patients - 24-Feb-2012

The ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System and TAXUS Liberte Paclitaxel-Eluting Coronary Stent System, from Boston Scientific, have received FDA approval for use in patients experiencing an Acute Myocardial Infarction or heart attack. They are the only US drug-eluting stent systems with an approved indication to treat patients with AMI. 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. Data from the HORIZONS-AMI trial showed that, in patients with AMI, paclitaxel-eluting stents were superior in efficacy to bare-metal stents, significantly reducing clinical and angiographic restenosis compared to bare-metal stents, while demonstrating a comparable safety profile at three years.