REMEDEE study of COMBO Dual Therapy Stent (Orbus Neich) meets primary endpoint

Data from the REMEDEE study of the COMBO Dual Therapy Stent, from Orbus Neich, demonstrated that the stent met the study's primary endpoint in CAD patients and was found to be effective in controlling neointimal proliferation. Specifically, the COMBO Stent was shown to be non-inferior to a drug eluting stent (DES) with respect to angiographic in-stent late lumen loss at nine months. The target lesion revascularization rate and the target vessel revascularization were 4.9 percent and 6.5 percent, respectively, for the COMBO Stent group and 8.5 percent and 10.2 percent, respectively, for the DES group.

No difference in mortality or occurrence of MI was observed, and no ST was reported in either group. Further, the COMBO Stent was shown to be safe, with an overall low rate of clinical events, a low rate of binary restenosis and no stent thrombosis (ST) observed up to 12 months. See: "The REMEDEE Trial:A Randomized Comparison of a Combination Sirolimus-Eluting Endothelial Progenitor Cell Capture Stent With a Paclitaxel-Eluting Stent" Michael Haude et al. J Am Coll Cardiol Intv. 2013;6(4):334-343. doi:10.1016/j.jcin.2012.10.018