Taxus Liberté Long and Atom Stents Approved by FDA

July 16, 2009—Boston Scientific Corporation (Natick, MA) announced that it has received US Food and Drug Administration (FDA) approval to market the Taxus Liberté Long paclitaxel-eluting coronary stent system. On May 27, Boston Scientific announced it has received FDA approval to market its Taxus Liberté Atom paclitaxel-eluting coronary stent system for the treatment of coronary vessels as small as 2.25 mm in diameter. The Taxus Liberté Long will be launched in August and the the Taxus Liberté Atom was launched in June in the United States.

According to the company, at 38 mm, the Taxus Liberté Long stent is designed for treating long lesions and can potentially reduce the number of stents used in more complex cases, simplifying procedures and reducing costs.

Boston Scientific stated that in the TAXUS ALTAS Long Lesion trial, the Liberté Long stent met its primary endpoint of noninferiority to the trial control stent (Taxus Express), in 9-month percent diameter stenosis (31.7% vs 32.6%; P = .71) and reported a 36% reduction in major adverse coronary events (9.4% vs 14.8%; P = .16). The trial reported a significant 79% in the rate of 9-month myocardial infarction for the Liberté Long as compared to the Express (1.3% vs 6.3%; P = .026). At 2 years, the composite measure of cardiac death or myocardial infarction showed a significant 63% reduction for the Liberté Long compared to the Express (3.5% vs 9.4%; P = .0426). The rate of stent thrombosis at 2 years was 0% for the Liberté Long stent and 0.8% for the Express stent.

The company said that the Liberté Atom stent is approved for treating small vessels (< 2.5 mm). The device features thin struts for improved deliverability and conformability and uniform stent geometry for consistent lesion coverage and drug distribution.