Medical device maker Boston Scientific Corp. (BSX) announced Monday that it has enrolled the first patient for its Taxus Liberte post-approval study to evaluate clinical outcomes in patients with coronary artery disease.
The first patient was enrolled at the Ingham Regional Medical Center in Lansing, Michigan. The program will further enroll approximately 4,200 patients at up to 65 sites in the U.S.
The study will test clinical outcomes of the Taxus Liberte Paclitaxel-Eluting Coronary Stent System in combination with a dual anti-platelet therapy drug regimen that includes aspirin and Effient.
Effient is manufactured by Eli Lilly and Company (LLY) and Daiichi Sankyo, Inc., who are also co-sponsors for the study. In July 2009, Effient was approved by the U.S. Food and Drug Administration.
The primary endpoint of the study is the rate of cardiac death or myocardial infarction at 12 months. Secondary endpoints will be analyzed out to five years and include rates of stent thrombosis using the Academic Research Consortium definition, target vessel failure, target vessel revascularization, myocardial infarction, bleeding events and stroke.
The Taxus Liberte Stent received CE Mark approval in 2005, U.S. FDA approval in 2008 and Japanese approval in 2009.
Boston Scientific also plans to contribute data on the first 1,524 eligible patients from the Taxus Liberte study to the DAPT Study; a collaboration between the FDA, drug and device manufacturers, and the Harvard Clinical Research Institute. This four-year public health study will investigate the appropriate duration of dual antiplatelet therapy following drug-eluting stent implantation.
BSX is currently trading at $9.03, up $0.03 or 0.33%, on a volume of 5.30 million shares, while LLY is trading at $36.16, up $0.45 or 1.25%, on a volume of 1.40 million shares, both on the NYSE.
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