The third and final pre-market approval (PMA) module contains nine-month data from the ATLAS clinical trial, a global, multi-center, pivotal study designed to support FDA approval of the Taxus Liberte system in the US.
“Since its launch last year in international markets, the Taxus Liberte system has achieved a leadership position in virtually every market where it is sold,” said Jim Tobin, president and CEO of Boston Scientific.
Boston recently received a warning letter from the FDA that raised quality control issues. The company is currently working with the FDA to address these concerns, but final approval of the stent will not be granted by the agency until it is convinced that the quality control issues have been resolved.
Boston Scientific launched its Taxus Liberte stent system in select international markets in January 2005 and received the CE Mark in Europe in September 2005. In April 2005, the company received US FDA approval for its Liberte bare-metal coronary stent system.