Stent Gains CE Approval to Treat Diabetic Patients


May 12, 2010
The Taxus Element stent.

May 12, 2010 – A paclitaxel-eluting coronary stent received CE mark approval for a specific indication to treat diabetic patients. The Taxus Element incorporates a platinum chromium alloy and a new stent design.

The Boston Scientific plans to launch the stent in June in the European Union and other CE mark countries.

“In my experience, the platinum chromium alloy and new stent design used in the Taxus Element Stent offer increased flexibility, visibility and deliverability,” said Dean Kereiakes, M.D., medical director at The Christ Hospital Heart and Vascular Center and The Lindner Research Center in Cincinnati. He served as the principal investigator for the stent’s PERSEUS clinical trial. “The Element platform represents a significant advance in coronary stenting with performance improvements that could simplify procedures and allow treatment of a broader range of patients. The combination of the proven Taxus drug and polymer with the new Element platform provides a welcome treatment option.”

In trials, paclitaxel has shown an ability to inhibit restenosis in high-risk patients with diabetes.

The stent architecture and proprietary platinum chromium alloy combine to offer greater radial strength and flexibility. The stent architecture helps create consistent lesion coverage and drug distribution, while improving deliverability. The higher density alloy provides better visibility and reduced recoil, while permitting thinner struts.

The company received CE mark approval for the Promus Element everolimus-eluting stent in October 2009. Both Element systems incorporate the same platinum chromium alloy and stent design.

In the United States, the Taxus Element stent and the Promus Element are investigational devices and are not available for sale. The company expects U.S. Food and Drug Administration (FDA) approval for the Taxus Element in mid-2011, and for the Promus Element in mid-2012. In Japan, the company expects approval for the Taxus Element in late 2011 or early 2012, and for the Promus Element in mid-2012.

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