Boston Scientific has received CE mark approval in Europe for its drug-eluting stent (DES) technology Taxus Element Paclitaxel-Eluting Coronary Stent System. The approval includes a specific indication for the treatment of diabetic patients.
Boston Scientific Taxus Element Stent System incorporates a platinum chromium alloy with a new stent design and an advanced catheter delivery system. The company plans to launch the Taxus Element Stent System next month in the European Union and other CE mark countries.
Boston Scientific said that the Taxus Element Stent is designed specifically for coronary stenting and leverages the performance advantages of the Element platform with a decade of clinical success from the Taxus program. The stent architecture and 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, 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 prior-generation stent.
Hank Kucheman, executive vice president and group president of cardiology, rhythm and vascular at Boston Scientific, said: “As the worldwide prevalence of diabetes continues to increase dramatically, the diabetic indication for the Taxus Element Stent System represents an important benefit for diabetic patients being treated for coronary artery disease.
“The Taxus Element Stent System, with the proven performance of paclitaxel, provides an advanced treatment option for diabetic patients. This product’s unique mechanism of action helps to inhibit restenosis in high-risk patients with diabetes, and we are pleased to offer it to these patients.”