The US Food and Drug Administration (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 with acute myocardial infarction (AMI).
The approval was based on the FDA’s review of data from the Paclitaxel (TAXUS) clinical program and Horizons-AMI trial.
The randomized Horizons-AMI trial, which enrolled 3,006 patients, received either drug-eluting stents or bare-metal stents.
Boston Scientific global chief medical officer Keith Dawkins said the AMI indication is a testament to their long-term commitment to innovation and leading clinical science in support of advanced drug-eluting stent (DES) technologies.
"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," Dawkins said.
"We are proud that our investments in randomized trials such as Horizons-AMI have led to the approval of products to treat a broader range of patients with coronary artery disease."
Boston Scientific CEO Hank Kucheman said the AMI 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 ION platinum chromium stent has been very well received since its US launch last year based on its exceptional visibility, radial strength and deliverability," Kucheman said.