Boston Scientific’s stent receives CE Mark approval for use in diabetics

As a result of the expanded CE Mark, the Taxus Liberte stent system in the EU is indicated for treatment of de novo and restenotic lesions or total occlusions in patients with coronary artery disease – angina, silent ischemia, acute myocardial infarction – to improve luminal diameter and reduce restenosis within the stent and at the stent edges in native coronary arteries. The Taxus Liberte stent system is also indicated for patients with concomitant diabetes mellitus as well as treatment of abrupt or threatened closure in patients with failed interventional therapy.

The Taxus Liberte stent system is pending approval by the FDA and is not available for sale in the US.

David McFaul, senior vice president of International for Boston Scientific, said: “We are offering another specific solution for diabetic patients outside the US, who are typically at higher risk for adverse events compared to non-diabetic patients.”