"We are pleased to see the strong performance of the TAXUS Element Stent in both the overall population of the PERSEUS trial and the diabetic patient subset," said Hank Kucheman, Executive Vice President and Group President, Cardiology, Rhythm and Vascular for Boston Scientific.  "As the worldwide prevalence of diabetes continues to increase dramatically, these findings are very encouraging for physicians and their patients."

Diabetes is generally associated with an increased risk of cardiovascular events and patients with diabetes are more likely than non-diabetic patients to require repeat procedures due to a higher incidence of restenosis following angioplasty and stenting.

In March, the Company announced one-year results from its PERSEUS clinical program demonstrating positive safety and efficacy outcomes for the TAXUS Element Stent System compared to prior-generation Boston Scientific stents in more than 1,486 patients in two parallel trials at 90 centers worldwide.  

The TAXUS Element Paclitaxel-Eluting Stent System received CE Mark approval in May, which included a specific indication for the treatment of diabetic patients.  The Company received CE Mark approval for the PROMUS?® Element?„? Everolimus-Eluting Stent System in October 2009.  Both Element systems incorporate the same platinum chromium alloy, innovative stent design and advanced catheter delivery system.

The Company expects U.S. 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 the U.S., the TAXUS Element (ION) Stent and the PROMUS Element Stent are investigational devices and are limited by applicable law to investigational use only and are not available for sale.

SOURCE Boston Scientific Corporation