HONG KONG, OrbusNeich announced that the Combo Dual Therapy Stent was featured today during a lunch symposium at the Angioplasty Summit TCTAP 2012 in Seoul, Korea. The symposium entitled “The Next Era: Combo Dual Therapy Stent” was chaired by Drs. Seung Jung Park and Harry Suryapranata.

Roxana Mehran, M.D., FACC, professor of medicine and director of interventional cardiovascular research and clinical trials at the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Medical Center, gave a talk entitled “The Next Era: Combo Dual Therapy Stent.”

“In interventional cardiology research, two of the most important goals are the elimination of complications following stent implantation and the reduction of DAPT duration,” said Dr. Mehran. “With Combo, the concept of a stent that achieves good clinical outcomes, promotes healing and reduces our dependence on long-term dual antiplatelet therapy is very encouraging.”

Interim results from EGO-COMBO, an optical coherence tomography (OCT) study of early healing with the Combo Stent, were highlighted by Prof. Stephen W.L. Lee, M.D., chief of cardiology, professor and senior consultant, Department of Medicine, Queen Mary Hospital, University of Hong Kong, showing that the Combo Stent approaches 70 percent strut coverage in less than 50 days and 100 percent coverage by 140 days during his talk titled “A Scientific and Rational Approach to Delineate Future Stent Platforms.”

Over a longitudinal follow up period of one year, at 9 months, the late loss was 0.32mm. Furthermore, at 12 months clinical follow up only one patient of the 61 enrolled had non-ischemic (angiographic) driven target lesion revascularization, which was treated by simple ballooning. There were no observations of stent thrombosis, myocardial infarction, or death, leading to an overall target vessel failure of 1.6 percent.

“This is the first study to establish the early healing profile of the Combo Stent using OCT,” said Prof. Lee. “In less than two months, we observe that strut coverage approaches 70 percent – the threshold indicated by the literature to correspond with a reduced risk of stent thrombosis. The Combo Stent is a very novel device with dual therapy properties suppressing neointimal while at the same time accelerating endothelial coverage on the luminal side of the stent for the prevention of thrombosis.”

Stephen M. Rowland, Ph.D., vice president of research and development at OrbusNeich, presented a summary of the Combo Dual Therapy Stent technology and development as well as the clinical data available today. These data included analyses from the REMEDEE trial that compared angiographic and intravascular ultrasound (IVUS) endpoints for the Combo Dual Therapy Stent versus the TAXUS® Liberté® paclitaxel-eluting stent.

“At nine months, we observed differences in the presentation and morphology of restenosis between the two stents,” said Dr. Rowland. “Specifically, with Combo we found in-stent restenosis to be more focal, whereas restenosis for Taxus was predominantly diffuse. In terms of morphology, we saw that with Combo, tissue response was more homogeneous versus more heterogeneous with Taxus. These distinctions corresponded with marked differences in clinical results.”

OrbusNeich’s Combo Stent is the first in a new category of dual therapy stents (DTS) that leverages a partitioned effect, combining an abluminal sirolimus drug elution for the control of neointimal proliferation with OrbusNeich’s Genous&™ pro-healing technology for the acceleration of endothelial coverage.

Source: OrbusNeich