Boston Scientific’s (NYSE:BSX) Ion and Taxus Liberté drug-eluting stents won pre-market approval from the FDA to treat heart attack patients.
The Natick, Mass.-based med-tech maker said the devices, which elute the anti-restenosis drug paclitaxel, are the only DES approved to treat patients with acute myocardial infarction.
The stents are fashioned from Boston Scientific’s next-generation platinum-chromium alloy. The company said 10% of all coronary interventions are performed for patients having a heart attack.
“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,” chief medical officer Dr. Keith Dawkins said in prepared remarks.
“The new indication for heart attack patients should give U.S. physicians the confidence to treat this high-risk group with Boston Scientific’s advanced paclitaxel-eluting stent technology backed by a robust clinical program that spans 10 years of research,” added CEO Hank Kucheman.