FDA Clears Boston Scientific’s TAXUS Liberte Long Stent

July 16, 2009 – Boston Scientific Corp. today said its received approval from the FDA to market its TAXUS Liberte Long Paclitaxel-Eluting Coronary Stent System 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, Boston Scientific said. It affords a more efficient treatment option for the estimated 8-10 percent 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 and Vascular Research at Washington Adventist Hospital, Takoma Park, Md. "In the ATLAS Long Lesion Trial, the 38 mm TAXUS Liberte Stent significantly reduced myocardial infarction when compared to the TAXUS Express 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 percent vs. 6.3 percent). 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 percent vs. 9.4 percent). The rate of stent thrombosis at two years was zero percent for the TAXUS Liberte Long Stent and 0.8 percent for the TAXUS Express Stent(2).

Boston Scientific has the industry's widest range of coronary stent sizes. The TAXUS Liberte Stent Series is now available in 92 sizes, ranging from 2.25 mm to 4 mm in diameter and from 8 mm to 38 mm in length.

For more information: www.bostonscientific.com