REMEDEE Enrollment Completed to Study OrbusNeich's Combo Stent

September 24, 2010—OrbusNeich (Fort Lauderdale, FL) announced the completion of patient enrollment in the REMEDEE clinical trial of the Combo bioengineered sirolimus-eluting stent. The randomized trial is composed of 183 patients enrolled at sites in Asia, Australia, Europe, and South America. The Combo stent is designed to combine the prohealing technology used in OrbusNeich's Genous bioengineered R stent for rapid endothelial coverage with an abluminal sirolimus drug elution for the control of neointimal proliferation, the company stated.

According to OrbusNeich, the primary objective of REMEDEE is to demonstrate safety and effectiveness of the Combo stent compared to the Taxus Liberté paclitaxel-eluting stent (Boston Scientific Corporation, Natick, MA) 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 9 months postprocedure.

Secondary endpoints include all-cause and cardiac mortality, myocardial infarction, major adverse cardiac events, and stent thrombosis rates at 30 days, 9 months, and 1 through 5 years, as well as clinically driven target lesion revascularization, target vessel revascularization, and target lesion failure rates at the same follow-up times. The lesions treated are single de novo native coronary lesions ranging in diameter from ≥ 2.5 mm and ≤ 3.5 mm and lengths of ≤ 20 mm.

“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,” commented Michael Haude, MD, one of the REMEDEE trial's principal investigators. “Because the preclinical data demonstrate lower neointimal hyperplasia and improved endothelial coverage, we look forward to obtaining clinical confirmation of the results."

Alexandre Abizaid, MD, a principal investigator of the study, added "The concept and design of the Combo stent can provide a safe alternative for patients with a high risk of restenosis. We look forward to obtaining data from the REMEDEE study to determine the Combo stent's potential."