
Friday, July 17, 2009
Boston Scientific gets FDA nod for long coronary stent
By Mass High Tech staff
The U.S. Food and Drug Administration has granted approval for Boston Scientific Corp. to market the Taxus Liberte Long Paclitaxel-Eluting Coronary Stent System, the longest drug-eluting stent available, according to company officials. The company submitted its application for FDA approval in February.
The stent received European approval, with the CE Mark, in 2007. Boston Scientific said it is planning to launch the stent in the U.S. in August.
The 38-mm stent is designed to simplify procedures and costs for patients with long lesions, and it’s been found to lower instances of nine-month myocardial infarction by 79 percent, compared to the Taxus Express Stent, according to Mark Turco, director of the Center for Cardiac & Vascular Research at Washington Adventist Hospital in Takoma Park, Md.
Boston Scientific (NYSE: BSX) has 92 sizes available of the Taxus Liberte Stent Series, from 8 mm to 38 mm long, and from 2.25 mm to 4 mm in diameter.
Boston Scientific reported a net loss for fiscal 2008 of $2 billion on revenue of $8 billion.







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