Devices & Diagnostics

FDA OKs two Boston Scientific drug-eluting stents for heart attack patients

  Boston Scientific (NYSE:BSX) announced late Wednesday that the U.S. Food and Drug Administration has approved two drug-coated stent systems for heart attack patients. These are the first stents in the world to be cleared for patients suffering from the symptoms of acute myocardial infarction (AMI) or heart attack. The stents are the Ion and […]

 

Boston Scientific (NYSE:BSX) announced late Wednesday that the U.S. Food and Drug Administration has approved two drug-coated stent systems for heart attack patients. These are the first stents in the world to be cleared for patients suffering from the symptoms of acute myocardial infarction (AMI) or heart attack.

The stents are the Ion and Taxus Liberté Paclitaxel-Eluting Stent Systems, and they are approved for other indications as well. About 10 percent of coronary interventions involve AMI patients, according to the Massachusetts medical device firm.

“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,” said Hank Kucheman, chief executive officer of Boston Scientific, in a news release. “The AMI indication reinforces the safety and effectiveness of the Ion and Taxus Liberté paclitaxel-eluting stents in treating challenging patients and lesions in both clinical and real-world practice.”

Boston Scientific holds the largest share of the drug-eluting stent market, although revenue has been falling. In the fourth quarter, drug-eluting stent revenue worldwide was $356 million, down from $377 million a year ago.