NATICK, Mass., May 27 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced it has received approval from the U.S. Food and Drug Administration (FDA) to market its TAXUS(R) Liberte(R) Atom(TM) Paclitaxel-Eluting Coronary Stent System, 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(R) Express(R) Atom(TM) Stent as the only drug-eluting stents approved for small vessel use in the U.S. The Company plans to begin a full U.S. 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
|SOURCE Boston Scientific Corporation|
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