Boston Scientific submits PMA to FDA for Taxus Liberte stents
Boston Scientific has submitted to the FDA the final modules of its pre-market approval (PMA) applications for both its Taxus Liberte Atom paclitaxel-eluting coronary stent system and its Taxus Liberte Long paclitaxel-eluting coronary stent system.
If approved, the Natick, Mass.-based company said the Taxus Liberte Atom will become its second 2.25-mm diameter drug-eluting stent (DES) available in the U.S. The Taxus Liberte Long is designed to be the first 38-mm DES available in the U.S.
The PMA submissions include clinical data from the global, multi-center Taxus ATLAS small vessel and long lesion studies, designed to compare the performance of the Taxus Liberte Atom and Taxus Liberte Long stents with Boston Scientific's first-generation Taxus Express stent. Although the second-generation Taxus Liberte stent uses identical drug dose, polymer and release kinetics as the Taxus Express stent, it features thinner struts and a uniform architecture designed for drug delivery, the company said.
If approved, the Natick, Mass.-based company said the Taxus Liberte Atom will become its second 2.25-mm diameter drug-eluting stent (DES) available in the U.S. The Taxus Liberte Long is designed to be the first 38-mm DES available in the U.S.
The PMA submissions include clinical data from the global, multi-center Taxus ATLAS small vessel and long lesion studies, designed to compare the performance of the Taxus Liberte Atom and Taxus Liberte Long stents with Boston Scientific's first-generation Taxus Express stent. Although the second-generation Taxus Liberte stent uses identical drug dose, polymer and release kinetics as the Taxus Express stent, it features thinner struts and a uniform architecture designed for drug delivery, the company said.