Drug eluting stents have become commonplace, but they effectively slow down healing and endothelium formation in exchange for an open lumen through which blood can flow with little interference. Because of this, patients spend months on dual antiplatelet therapy (DAPT), which has its own side effects besides the extended healing time of tissue around the stent.
Hong Kong-based OrbusNeich announced that it’s launching COMBO, the world’s first stent to offer sirolimus elution to prevent restenosis, as well as technology to capture endothelial progenitor cells (EPC) from passing blood to accelerate healing. The stent is coated with Anti-CD34 antibodies that capture EPCs to form a layer around the stent surface. The EPCs then differentiate into endothelial cells to create a natural coating just like the inside of the artery in which the stent is positioned.
- Ongoing first-in-man, prospective, randomized, multi-center study at sites in Asia, Australia, Europe and South America that enrolled 183 patients with symptomatic, ischemic heart disease due to a stenotic lesion located in a native coronary artery; twelve-month results published in the April 2013 edition of JACC: Cardiovascular Interventions
- Data showed that the COMBO Dual Therapy Stent was effective for the sustained control of neointimal proliferation; at nine-month angiographic follow-up, the in-stent late lumen loss for the COMBO Stent was 0.39 +/- 0.45 mm compared to 0.44 +/- 0.56 mm for the control drug eluting stent; this is well below the threshold of 0.50 mm shown in the literature to be effective in preventing repeat revascularization
- The COMBO Dual Therapy Stent was shown to be safe, with an overall low rate of clinical events, a low rate of binary restenosis and no stent thrombosis observed up to 12 months; the major adverse cardiac event (MACE) rate at 12 months was 8.9% for the COMBO Stent group and 10.2% for the drug eluting stent group; the clinically driven target lesion revascularization (TLR) rate was 4.9% for the COMBO Stent group versus 8.5% for the drug eluting stent group
Product page: COMBO Dual Therapy Stent…