PARIS, May 15, 2012 /PRNewswire/ -- OrbusNeich today announced that 12-month follow-up data from the REMEDEE study showed favorable clinical and safety outcomes involving the use of the company's Combo Dual Therapy Stent when compared to the TAXUS® Liberte® paclitaxel-eluting stent. The data were presented by Michael Haude, M.D., of Medical Clinic I at the Lukaskrankenhaus in Neuss, Germany, at EuroPCR 2012.
In the 12-month follow-up data set, the clinically driven target lesion failure (TLF) rate was 8.9% for patients treated with the Combo Stent, compared to 10.2% for those treated with the TAXUS stent. Clinically driven TLF was defined as a composite of death, myocardial infarction (MI) and clinically driven target lesion revascularization (TLR). In addition, the rate of clinically driven TLR was 4.9% for patients treated with the Combo Stent, compared to 8.5% for those treated with the TAXUS stent. There was no stent thrombosis (ST) in either of the groups.
"The in-stent and in-segment late loss and binary restenosis rates were accordingly low for the Combo Stent and comparable to those of the TAXUS stent," said Prof. Haude. "Additionally, we saw a uniform, homogeneous neointimal response with the Combo Stent, compared to the more heterogeneous and layered neointimal tissue appearance with the TAXUS stent. Other data are being presented this week, and we look forward to presenting two-year follow-up and other results of the REMEDEE study at upcoming conferences."
REMEDEE (Randomized Evaluation of an abluMinal sirolimus coatED bio-Engineered stEnt) is a randomized clinical trial designed to demonstrate the safety and efficacy of the Combo Dual Therapy Stent compared to the TAXUS stent in patients with symptomatic, ischemic heart disease due to a stenotic lesion located in a native coronary artery. The study's primary en
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