October 10, 2008 - Boston Scientific Corp. today said it received FDA approval to market its second-generation TAXUS Liberte Paclitaxel-Eluting Coronary Stent System and the company plans to launch the stent early next month in the U.S.
The introduction will take place following completion of the introduction of its TAXUS Expresss2 Atom Paclitaxel-Eluting Coronary Stent System, which was approved by the FDA last month. The TAXUS Liberte stent was launched in Europe and other international markets in 2005.
The company said the new stent has substantially thinner struts and a more flexible cell geometry for improved deliverability, as well as uniform strut distribution designed specifically for drug elution.
The TAXUS stent systems - both Liberte and Express2 - have been evaluated by the industry’s most extensive randomized, controlled clinical trial program, with follow-up to five years in some cases. These trial results have been supplemented by data on more than 35,000 patients enrolled in post-approval registries. To date, about 4.6 million TAXUS stents have been implanted globally, making them the world’s most frequently used drug-eluting stents, the company said.
The TAXUS Express2 stent (not the newer TAXUS Liberte stent) was used as the control against Abbott’s Xience V Everolimus-Eluting Coronary Stent System in the SPIRIT II and III trials.
The TAXUS Liberte Stent is not available for sale in Japan, where it is undergoing regulatory review.
For more information: www.bostonscientific.com