WASHINGTON, Sept. 24 /PRNewswire/ — OrbusNeich today announced
at the Transcatheter Cardiovascular Therapeutics (TCT) 2010 in
Washington the completion of patient enrollment in the randomized
clinical trial of the Combo Bio-engineered Sirolimus Eluting Stent
(Combo Stent) with 183 patients included at sites in Asia,
Australia, Europe and South America.
“Completion of enrollment of this study represents a significant
milestone as we look to validate the potential for the Combo Stent
in a clinical setting,” said Al Novak, Chairman and CEO of
OrbusNeich.
The primary objective of the prospective, randomized,
multicenter study, called REMEDEE (Randomized
Evaluation of an abluMinal sirolimus
coatED bio-Engineered
stEnt), is to demonstrate safety and effectiveness of
the Combo Stent compared to the TAXUS® Liberte®
paclitaxel-eluting stent in patients with symptomatic, ischemic
heart disease due to a stenotic lesion located in a native coronary
artery. This objective will be measured in patients by a comparison
of in-stent late lumen loss at nine months post-procedure.
Michael Haude, M.D., director of Medical Clinic I at the
Lukaskrankenhaus in Neuss, Germany, and one of the trial’s
principal investigators, added, “The Combo Stent has the potential
to bring a unique treatment option to physicians by combining the
proven Genous endothelial progenitor cell capture technology with a
low dose sirolimus elution. Because the pre-clinical data
demonstrate lower neointimal hyperplasia and improved endothelial
coverage, we look forward to obtaining clinical confirmation of the
results.”
Secondary endpoints include all-cause and cardiac mortality,
myocardial infarction, Major Adverse Cardiac Event (MACE) and stent
thrombosis rates at 30 days, nine months and one through five
years, as well as clinically driven Target Lesion Revascularization
(TLR), Target Ves
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