The U.S. Food and Drug Administration has given its approval for Boston Scientific Corp.'s Ion paclitaxel-eluting platinum chromium coronary stent system and Taxus Liberte pacitaxel-eluting coronary stent for use in patients experiencing an acute myocardial infarction (AMI), or heart attack.
According to the Natick, Mass.based cardiovascular device giant, the devices are the only drug-eluting stent (DES) systems in the United States with an approved indication to treat patients with AMI.
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 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 American Heart Association estimates that death by heart attack accounts for one out of every six deaths annually in the United States. There are more than 1.2 million new and recurrent cases of heart attack each year, with approximately 34 percent resulting in death.