Boston Scientific Corp. (NYSE:BSX) received CE Mark approval in the European Union for a new indication for its everolimus-eluting Promus Element coronary stent system.
Cardiologists may now deploy the platinum chromium alloy drug-eluting stents in patients with concomitant diabetes mellitus and in those experiencing an acute myocardial infarction, or heart attack.
The Natick, Mass.-based company received CE Mark approval for the stent in October 2009 and launched its Taxus Element paclitaxel-eluting stent system in June. The Taxus Element’s approval also included a specific indication for the treatment of diabetics.
The Promus Element stent has only investigational device status in the U.S., but BSX expects its approval in mid-2012, when the company expects Japanese approval as well, according to a press release.