Boston Scientific receives industry’s first FDA approval for drug-eluting coronary stent use in heart attack patients


Boston Scientific’s Ion Paclitaxel-Eluting Platinum Chromium Coronary Stent System and Taxus Liberte Paclitaxel-Eluting Coronary Stent System have received FDA approval for use in patients experiencing an acute myocardial infarction on 22 February 2012. They are the only drug-eluting stent systems in the USA with an approved indication to treat patients with acute myocardial infarction.

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 programme and HORIZONS-AMI trial. In the global HORIZONS-AMI trial, 3,006 patients were randomised to receive either drug-eluting stents or bare metal stents for the treatment of acute myocardial infarction, making it the largest randomised trial to study coronary stents in heart attack patients. 


“The acute myocardial infarction indication is a testament to our long-term commitment to innovation and leading clinical science in support of advanced drug-eluting stent technologies,” said Keith D Dawkins, Global chief medical officer for Boston Scientific. “”Clinical data from the HORIZONS-AMI trial showed that, in patients with acute myocardial infarction, 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. We are proud that our investments in randomised trials such as HORIZONS-AMI have led to the approval of products to treat a broader range of patients with coronary artery disease.”


“The new indication for heart attack patients should give US physicians the confidence to treat this high-risk group with Boston Scientific’s advanced paclitaxel-eluting stent technology backed by a robust clinical programme that spans 10 years of research,” said Hank Kucheman, chief executive officer of Boston Scientific. “The acute myocardial infarction indication reinforces the safety and effectiveness of the Ion and Taxus Liberte paclitaxel-eluting stents in treating challenging patients and lesions in both clinical and real-world practice. 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 US launch last year based on its exceptional visibility, radial strength and deliverability.”


The company’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.