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.
