Data Support OrbusNeich's Genous R Stent Combined With Drug-Eluting Balloon

June 21, 2010—OrbusNeich (Fort Lauderdale, FL) announced that 6-month clinical follow-up data show the safety and efficacy of combining predilatation with a paclitaxel drug-eluting balloon (Sequent Please, B. Braun Interventional Systems Inc., Bethlehem, PA) followed by implantation of the company's Genous bioengineered R stent for the percutaneous treatment of coronary artery stenosis. Alan Yean Yip Fong, MD, presented the data during the World Congress of Cardiology Scientific Sessions 2010 in Beijing, China.

According to the company, in the investigator-initiated, single-center, all-comers POTENT (Paclitaxel-eluting Balloon and Bio-engineered Progenitor Cell-Attracting Stainless Steel Stent in Percutaneous Treatment of Coronary Artery Stenosis) registry, 32% of patients were diabetic, 86% were men, 58% had a previous myocardial infarction, and the mean age of the study population was 56 years. Of the lesions treated, 46% were type B2/C lesions. The patients received a preloading of dual-antiplatelet therapy (DAPT) at least 6 hours before the intervention, and DAPT was continued for 3 months after the procedure. There were no in-hospital or 30-day major adverse cardiac events (MACE) reported; there was one case of late stent thrombosis.



At 6-month clinical follow-up of 50 patients in the study, the investigators found a 6% MACE rate and a 4% clinically driven target lesion revascularization rate. In an optional 9-month angiographic follow-up of 35 patients, no patients exhibited binary restenosis. 

“We are very encouraged by the low MACE and binary restenosis rates, which are comparable to other stenting strategies and demonstrate the potential for combining drug-eluting and pro-healing technologies,” commented the study's principal investigator, Tiong-Kiam Ong, MD. “This therapeutic strategy could be a potent remedy for the dual problem of in-stent restenosis and stent thrombosis.”