FDA OKs Boston Scientific Taxus Liberte after two-year delay

Taxus Liberte paclitaxel-eluting coronary stent system. Image source: Boston Scientific

Boston Scientific has received approval from the FDA to market its second-generation Taxus Liberte paclitaxel-eluting coronary stent system.

In 2006, the FDA placed a two-year ban on the Taxus Liberte drug-eluting stent due to a corporate warning letter over the company’s manufacturing violations.

The Natick, Mass.-based company plans to launch the Taxus Liberte stent early next month in the U.S., following completion of the introduction of its Taxus Expresss2 Atom paclitaxel-eluting coronary stent system, which was approved by the FDA last month.

According to Boston Scientific, the Taxus stent systems—both Liberte and Express2—have been evaluated through an extensive randomized, controlled clinical trial program, with follow-up to five years in some cases. The trial results have been supplemented by data on more than 35,000 patients enrolled in post-approval registries.  

The Liberte stent was launched in Europe and other international markets in 2005, and it received a CE Mark in December 2007 for use in diabetic patients. However, the Liberte is not available for sale in Japan, where it is undergoing regulatory review.