FINAL MODULE FOR TAXUS STENT SUBMITTED BY BOSTON SCIENTIFIC
Boston Scientific has submitted to the FDA its final module of the company's premarket approval application for its Taxus Liberte paclitaxel-eluting coronary stent system.
This third module contains nine-month data from the Atlas clinical trial, a global study designed to support FDA approval of the Taxus stent in the U.S. The stent received the CE Mark in Europe in September 2005. The company received FDA approval for the Liberte bare-metal stent system in April 2005.
The data from the trial will be announced at the upcoming EuroPCR conference, to be held in Paris in May.