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Boston Scientific Receives FDA Approval For Next-Generation TAXUS Liberte Atom Stent System

Boston Scientific Corporation announced it has received approval from the US Food and Drug Administration (FDA) to market its TAXUS Liberte Atom Paclitaxel-Eluting Coronary Stent System. It is a highly deliverable, next-generation drug-eluting stent (DES) specifically designed for treating small coronary vessels. It was approved for use in vessels as small as 2.25 mm 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 Mark Turco, M.D., F.A.C.C., F.S.C.A.I., Director of the Center for Cardiac and Vascular Research at Washington Adventist Hospital, Takoma Park, Maryland. 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 revascularization rate that was 60 percent 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 percent of patients undergoing percutaneous coronary interventions have small vessels (<2.5 mm). Until recently, many physicians were inclined to implant bare-metal stents in these patients since they were the only approved stenting option for small vessels. Last year’s launch of the TAXUS Express Atom Stent offered an alternative treatment choice for patients with small vessels who will now have the additional option of the TAXUS Liberte Atom Stent.

The TAXUS Liberte Stent features design improvements over the company’s first-generation TAXUS Express Stent, including thinner struts to allow better stent deliverability and conformability, as well as uniform stent geometry for consistent lesion coverage and drug distribution.

Boston Scientific offers the industry’s widest range of coronary stent sizes. The company expects to expand its stent portfolio later this year with the first 38 mm long DES, the TAXUS Liberte Long Stent, which is currently under review with the FDA.

TAXUS Stents have been evaluated by the industry’s most extensive randomized, controlled clinical trial program, with follow-up to five years in some cases. These trial results have been supplemented by data on more than 35,000 patients enrolled in post-approval registries. To date, approximately 11 million Boston Scientific stents have been implanted globally, making them the world’s most frequently used stents.