FDA approves second-generation TAXUS Liberte Paclitaxel-Eluting Coronary Stent System

Oct 12 2008

Boston Scientific Corporation has announced it has received approval from the U.S. Food and Drug Administration (FDA) to market its second-generation TAXUS Liberte Paclitaxel-Eluting Coronary Stent System.

The Company plans to launch the TAXUS Liberte stent early next month in the United States, following completion of the introduction of its TAXUS Expresss2(TM) Atom(TM) 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 TAXUS Liberte stent represents our latest advance in drug-eluting stent technology," said Donald Baim, M.D., Chief Medical and Scientific Officer of Boston Scientific. "This device 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 Liberte stent demonstrated similar late loss and target vessel revascularization (TVR) as the TAXUS Express2(TM) Paclitaxel-Eluting Coronary Stent System in the ATLAS Workhorse clinical trial, despite treating more challenging patients."

"We believe the approval of TAXUS Liberte is a clear indication that we have made significant progress toward resolving the issues related to the Corporate Warning Letter," said Jim Tobin, President and Chief Executive Officer of Boston Scientific.

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, approximately 4.6 million TAXUS stents have been implanted globally, making them the world's most frequently used drug-eluting stents.

The TAXUS Express2 stent (not the newer TAXUS Liberte stent) was used as the control against the Xience(TM) V Everolimus-Eluting Coronary Stent System in the SPIRIT II and III trials. XIENCE is a trademark of the Abbott Laboratories group of companies.

The TAXUS Liberte Stent is not available for sale in Japan, where it is undergoing regulatory review.