FDA Approves Boston Scientific's TAXUS(R) Liberte(R) ...( NATICK Mass. July 16 /- B...),Health

NATICK, Mass., July 16 /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)) Long Paclitaxel-Eluting Coronary Stent System, a next-generation drug-eluting stent (DES) designed for long lesions. At 38 mm, it is the longest available DES, providing doctors an option that can potentially reduce the number of stents used in more complex cases, simplifying procedures and reducing costs. It affords a more efficient treatment option for the estimated 8 to 10 percent(1) of patients with long lesions. The Company plans to launch the product in the U.S. next month. It received CE Mark approval in 2007.

"The TAXUS Liberte Long Stent offers physicians and patients distinct advantages compared to using two overlapping drug-eluting stents," said Mark Turco, M.D., FACC, FSCAI, Director of the Center for Cardiac & Vascular Research at Washington Adventist Hospital, Takoma Park, Maryland. "In the ATLAS Long Lesion Trial, the 38 mm TAXUS Liberte Stent significantly reduced myocardial infarction when compared to the TAXUS((R)) Express((R)) Stent, making the TAXUS Liberte Long Stent an attractive option for interventional cardiologists faced with long, challenging lesions."

The TAXUS ATLAS Long Lesion Trial reported a significant 79 percent reduction in the rate of nine-month myocardial infarction for the TAXUS Liberte Long Stent as compared to the TAXUS Express Stent control (1.3% vs. 6.3%, p=0.026). At two years, the composite measure of cardiac death or myocardial infarction showed a significant 63 percent reduction for the TAXUS Liberte Long Stent compared to the TAXUS Express Stent (3.5% vs. 9.4%, p=0.0426). The rate of stent thrombosis at two years was zero percent f
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