The FDA has approved Boston Scientific’s Ion Paclitaxel-Eluting Platinum Chromium Coronary Stent System and Taxus Liberte Paclitaxel-Eluting Coronary Stent System for use in patients experiencing an acute myocardial infarction (AMI), or heart attack.
The AMI indication, which accounts for approximately 10% of all coronary interventions, is a result of FDA review of data from the HORIZONS-AMI trial of 3,006 patients who received either drug-eluting stents or bare-metal stents for the treatment of AMI. It was the largest randomized trial to study coronary stents in heart attack patients.
"Clinical 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,” said Keith D. Dawkins, M.D., global CMO for Boston Scientific.
Boston Scientific’s Ion Stent System incorporates a unique platinum chromium (PtCr) alloy designed specifically for coronary stenting and intended to improve the acute performance of coronary stent implantation in the treatment of coronary artery disease.
“The inclusion of the Ion stent for this indication should be welcome news for physicians and patients. This innovative platinum chromium stent has been very well received since its U.S. launch last year based on its exceptional visibility, radial strength and deliverability,” said Hank Kucheman, CEO of Boston Scientific.
Ion and Taxus are the only drug-eluting stent (DES) systems in the U.S. with an approved indication to treat patients with AMI.