Boston Scientific has reported the market launch and first implants of its Taxus Element Paclitaxel-Eluting Coronary Stent System in the European Union and other CE mark countries. CE mark approval includes specific indication for treatment of diabetic patients.
Boston Scientific said that the Taxus Element Stent System is the company’s third-generation drug-eluting stent (DES) technology and incorporates a platinum chromium alloy with an innovative stent design and an advanced catheter delivery system. It has received CE mark approval previous month, which included a specific indication for the treatment of diabetic patients.
The Taxus Element Stent is designed specifically for coronary stenting and leverages the performance advantages of the Element Stent platform with a decade of clinical success from the Taxus program. 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, 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 stents.
Reportedly, in March, the company has presented 12-month results from its Perseus clinical program demonstrating positive safety and efficacy outcomes in workhorse lesions for the Taxus Element Stent System compared to the Taxus Express2 Stent System. Those results were recently published in the Journal of the American College of Cardiology.
Boston Scientific said that the Perseus results also reported a similar safety profile and statistically superior efficacy outcomes in small vessels for the Taxus Element Stent compared to a historical control group of patients receiving the Express bare-metal Stent.
In the US, the company expects FDA 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 US and Japan, the Taxus Element 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.
Corrado Tamburino, chair of the cardiology department at Ferrarotto Hospital, said: “I have found the Taxus Element Stent to offer performance advantages in flexibility, visibility and deliverability over prior-generation stents. The platinum chromium alloy and new stent design used in the Element platform, together with the proven Taxus drug and polymer, represent a significant advance in coronary stenting.”