Genous Bio-engineered R Stent With Drug-Eluting Balloon Safe, Effective: OrbusNeich

OrbusNeich said that, 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 male, 58% had a previous myocardial infarction and the mean age of the study population was 56 years.

According to the study data, of the lesions treated, 46% were type B2/C lesions. The patients received a pre-loading of dual antiplatelet therapy (DAPT) at least six hours prior to the percutaneous coronary intervention, and the DAPT was continued for three months. There were no in-hospital or 30 day major adverse cardiac events (MACE) reported. There was one case of late stent thrombosis.

In the six-month clinical follow-up of the 50 patients in the study, the MACE rate was 6%, and the clinical driven target lesion revascularization (TLR) rate was 4%. In an optional nine-month angiographic follow-up of 35 patients, no patients exhibited binary restenosis.

Genous is OrbusNeich’s patented endothelial progenitor cell (EPC) capture technology that promotes the accelerated natural healing of the vessel wall after the implantation of blood-contact devices, such as stents.

The technology consists of an antibody surface coating that attracts EPCs circulating in the blood to the device to form an endothelial layer that provides protection against thrombosis and modulates restenosis.

Tiong-Kiam Ong of the Sarawak General Hospital in Malaysia and principal investigator of the study, said: “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.

“This therapeutic strategy could be a potent remedy for the dual problem of in-stent restenosis and stent thrombosis.”