A Medical Device Daily
Boston Scientific (Natick, Massachusetts) said that it has submitted to FDA the final modules of the company's PMA applications for both its Taxus Libert Atom paclitaxel-eluting coronary stent system and its Taxus Libert Long paclitaxel-eluting coronary stent system.
If approved, the Libert Atom stent will become the company's second 2.25 mm diameter drug-eluting stent (DES) available in the U.S.
Boston Scientific says that it will then likely succeed the Taxus Express Atom stent, the company's first approved small stent and the only DES currently approved by the FDA to treat small vessels. The Taxus Libert Long stent is designed to be the first 38 mm drug-eluting stent available in the U.S. and will further expand the company's DES portfolio.
These 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 Libert Long stents with Boston Scientific's first-generation Taxus Express stent. While the second-generation Libert stent uses identical drug dose, polymer and release kinetics as the Express stent, it features thinner struts and a uniform architecture specifically designed for drug delivery.
"We are pleased to have a second-generation small vessel DES and the U.S. market's first long DES under review by the FDA," said Jim Tobin, president/CEO of Boston Scientific."The rapid adoption of our recently approved Taxus Express Atom stent confirms the need for an expanded DES size matrix to treat the wide range of vessel anatomies seen in daily clinical practice."