Boston Scientific just received FDA approval to market the ION Platinum Chromium and TAXUS Liberté paclitaxel-eluting coronary stent systems for patients suffering from acute myocardial infarctions.
According to the company, these are the only drug-eluting stents approved by the FDA to have an explicit indication for use in heart attack victims.
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.
“The AMI indication is a testament to our long-term commitment to innovation and leading clinical science in support of advanced DES technologies,” said Keith D. Dawkins, M.D., Global Chief Medical Officer for Boston Scientific. “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. 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.”
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.