Boston Scientific's 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. The company plans to launch the device next month 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.

As reported on March 15, 2010 by Cardiac Interventions Today (click here), the company announced 12-month results from its PERSEUS clinical program demonstrating positive safety and efficacy outcomes in workhorse lesions (PERSEUS WH) for the Taxus Element stent system compared to the Taxus Express2 stent system. The results also demonstrated a similar safety profile and statistically superior efficacy outcomes in small vessels (PERSEUS SV) for the Taxus Element stent compared to a historical control group of patients receiving the Express bare-metal stent. The PERSEUS clinical program compared the Taxus Element stent to previous-generation Boston Scientific stents in more than 1,600 patients in two parallel trials at 90 centers worldwide.

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.

“In my experience, the platinum chromium alloy and new stent design used in the Taxus Element stent offer increased flexibility, visibility, and deliverability,” commented Dean Kereiakes, MD, the principal investigator for the PERSEUS clinical program. “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.”