Boston Scientific Corporation has received approval from the US FDA to market TAXUS Liberte Long Paclitaxel-Eluting Coronary Stent System. It is a next-generation drug-eluting stent (DES) designed for long lesions. It is 38 mm and is the longest DES, providing doctors an option which can reduce the number of stents used in more complex cases thus simplifying procedures. It affords a more efficient treatment option for the estimated 8 to 10 percent of patients with long lesions. It received CE Mark approval in 2007. The Company plans to launch the product in the US next month.
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 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% 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 for the TAXUS Liberte Long Stent and 0.8 percent for the TAXUS Express Stent.
The announcement is the latest example of the breadth of our market-leading drug-eluting stent portfolio, said Hank Kucheman, Senior Vice President and Group President, Cardiovascular for Boston Scientific. The TAXUS Liberte Long Stent and our TAXUS Liberte Atom Stent — approved by the FDA in May for use in small vessels — are key differentiators. No other company offers a 38 mm length or 2.25 mm diameter DES. Our ongoing leadership is due not only to the range and quality of our products but also to the success of our two-drug strategy, giving physicians the choice of both paclitaxel- and everolimus-based DES.
The TAXUS Liberte Stent Series is available in 92 sizes, ranging from 2.25 mm to 4.0 mm in diameter and from 8 mm to 38 mm in length