Taxus Element Approved in Europe

May 12, 2010—Boston Scientific Corporation (Natick, MA) announced it has received CE Mark approval for its Taxus Element paclitaxel-eluting coronary stent system. The approval includes a specific indication for the treatment of diabetic patients. On June 10, Boston Scientific announced the market launch of the Taxus Element in the European Union and other CE Mark countries.

According to the company, the Taxus Element stent is designed specifically for coronary stenting with novel stent architecture and the company's platinum chromium alloy for greater radial strength and flexibility. The stent's architecture helps create consistent lesion coverage and drug distribution to improve deliverability, which is enhanced by an advanced catheter delivery system. The higher-density alloy provides superior visibility and reduced recoil while permitting thinner struts compared to previous-generation stents.

In October 2009, Boston Scientific received CE Mark approval for the Promus Element everolimus-eluting stent system, which incorporates the same platinum chromium alloy, stent design, and catheter delivery system.

The company expects 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. 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.