Boston Scientific Corporation has got CE Mark approval for Promus Element Everolimus-Eluting Coronary Stent System for use in patients with diabetes and those experiencing an acute myocardial infarction (AMI).
The company claims that the Promus Element Stent features a novel platinum chromium alloy and stent design, which combine to offer greater radial strength and flexibility while reducing stent recoil.
The company expects the US Food and Drug Administration approval for the Taxus Element Stent System in mid 2011 and for the Promus Element Stent System in mid 2012.
However, in Japan, the company expects approval for the Taxus Element Stent System in late 2011 or early 2012 and for the Promus Element Stent System in mid 2012.
Boston Scientific’s Cardiology, Rhythm and Vascular Group senior vice president and chief medical officer Keith Dawkins said that they are pleased to receive these expanded indications for the high-risk diabetic and AMI patient groups.
“The platinum chromium Promus Element Stent has been well received by physicians since its launch last year in CE Mark countries, and these new indications are important additions, especially as the prevalence of diabetes continues to increase dramatically worldwide,” Dawkins said.