FDA approves Boston Scientific’s Taxus Liberte Long Stent


Boston Scientific announced on 16 July it has received approval from the FDA to market its Taxus Liberte long paclitaxel-eluting coronary stent system, a next-generation drug-eluting stent (DES) designed for long lesions.

At 38mm, 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% of patients with long lesions. The company plans to launch the product in the US 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, director of the Center for Cardiac & Vascular Research at Washington Adventist Hospital, Takoma Park, US. “In the ATLAS Long Lesion Trial, the 38mm 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% 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% 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 0% for the long stent and 0.8% for Taxus Express.

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