Boston Gets CE Mark For TAXUS Element Stent System
This approval includes an indication for the treatment of diabetic patients. The TAXUS Element stent system incorporates a platinum chromium alloy with a stent design and an advanced catheter delivery system. The company plans to launch the TAXUS Element Stent System in June 2010 in the European Union and other CE Mark countries.
The TAXUS Element Stent is designed 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 proprietary platinum chromium alloy combine to offer radial strength and flexibility.
In the US, the company expects 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.
Hank Kucheman, executive vice president and group president for cardiology, rhythm and vascular at Boston, 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.”
Will the new system enhance care benefits for diabetic patients?
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