Interventional device developer Boston Scientific has submitted to the U.S. Food and Drug Administration (FDA) the final modules of its premarket approval (PMA) applications for its Taxus Liberté Atom paclitaxel-eluting coronary stent system and its Taxus Liberté Long paclitaxel-eluting coronary stent system, the Natick, MA-based company said.
If approved, the Taxus Liberté Atom stent will become Boston Scientific's second 2.25-mm-diameter drug-eluting stent available in the U.S. and will succeed the Taxus Express Atom stent. The Taxus Liberté Long stent is designed to be a 38-mm drug-eluting stent and will further expand the company's drug-eluting portfolio.
The PMA submissions include clinical data from the global, multicenter Taxus Atlas small vessel and long lesion studies, designed to compare the performance of the Taxus Liberté Atom and Taxus Liberté Long stents with Boston Scientific's first-generation Taxus Express stent.
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