FDA approves next-generation Taxus Liberte Atom Stent System


Boston Scientific announced on 27 May 2009 it has received approval from the FDA to market its Taxus Liberte Atom Paclitaxel-Eluting Coronary Stent System, a highly deliverable, next-generation drug-eluting stent specifically designed for treating small coronary vessels.

The device was approved for use in vessels as small as 2.25mm in diameter and joins the Taxus Express Atom Stent as the only drug-eluting stents approved for small vessel use in the US. The Company plans to begin a full US launch of Taxus Liberte Atom next month.

“The rapid adoption of the Taxus Express Atom Stent has confirmed the need for this type of stenting option in the treatment of small-vessel coronary artery disease,” said Dr Mark Turco, Director of the Center for Cardiac and Vascular Research at Washington Adventist Hospital, Takoma Park, US. “The Taxus Liberte Atom Stent provides clear design and deliverability advantages. Additionally, in the Taxus Atlas Small Vessel clinical trial, the Taxus Liberte Atom Stent yielded a two-year target lesion revascularisation rate that was 60% less than the Taxus Express Atom Stent. I am pleased to be able to offer this option to my patients.”

Data from numerous clinical studies have shown that an estimated 10% of patients undergoing percutaneous coronary interventions have small vessels.

Boston Scientific expects to expand its stent portfolio later this year with the first 38mm long drug-eluting stent, the Taxus Liberte Long Stent, which is currently under review with the FDA.