HONG KONG, July 11, 2011 /PRNewswire/ -- OrbusNeich today announced that data from an ex vivo arteriovenous (AV) shunt model of human circulating blood, in addition to results from three preclinical studies, demonstrated that the Genous Stent effectively captures circulating CD34+ endothelial progenitor cells (EPCs) leading to accelerated re-endothelialization and decreased thrombogenicity compared to bare metal stents (BMS). These mechanistic data were published as an e-publication on the European Heart Journal website.
Data from the ex vivo human AV shunt study showed that EPC deposition on the struts of the Genous Stent was enhanced by 32.5 percent compared to BMS. In addition, the expression of specific endothelial markers increased significantly in cells deposited on the Genous Stent compared to those on the BMS. The data also showed a significant decrease in the expression of thrombotic markers associated with Genous.
"These data demonstrate the effectiveness of the capture of CD34+ cells for endothelialization and the prevention of thrombosis," said Eric J. Duckers, M.D., Ph.D., of the Thoraxcenter at Erasmus University Medical Center in Rotterdam, The Netherlands, and senior author of the publication. "This mechanism of early endothelialization supports the usage of Genous' unique EPC capture technology especially for patients who are at higher risk of thrombosis."
For the ex vivo human study, 15 patients undergoing coronary angiography received an extracorporeal femoral AV shunt containing a Genous Stent and a BMS, which were exposed to circulating blood for up to 120 minutes. The cell depositions on the struts were determined by confocal and scanning electron microscopic analysis (SEM). Expression of endothelial and thrombotic markers was determined using quantitative polymerase chain reaction (qPCR).
"We were able to see a significant difference between the Genous Stent and the bare metal stent in promoting EPC capture and reducing acute thrombogenicity," said Renu Virmani, M.D., of the CVPath Institute Inc. in Gaithersburg, Md., and co-author of publication. "The Genous Stent appears to not only promote the adhesion of human EPCs, but it also reduces the adhesion of fibrin, platelets and inflammatory cells, all of which are important for the prevention of thrombus."
Further studies validating the EPC capture concept were conducted in vitro and in two animal models. An in vitro cell-capture assay demonstrated a preferential adhesion of human peripheral blood-derived CD34+ cells to the Genous Stent, with 86 percent of the attached cells positive for CD34 compared to 26 percent of cells on the BMS. In a baboon AV shunt model, the investigators showed that the Genous Stent inhibits in-stent thrombosis, as indicated by a significant increase in platelet deposition on the BMS compared to the Genous Stent. In a rabbit endothelial denudation model, qPCR analysis of endothelial marker expression indicated that the Genous Stent significantly promotes re-endothelialization at seven days compared to BMS.
Genous is OrbusNeich's patented 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.
The Genous Stent, which has been commercially available in more than 60 countries since 2005, has been proven as a safe, effective alternative to drug eluting stents and is supported by data from more than 6,000 patients in company-sponsored clinical studies. There is a growing body of evidence from multiple clinical studies that the Genous Stent is effective for patients who are non-responsive to or cannot tolerate long-term dual antiplatelet therapy.
OrbusNeich is a global company that designs, develops, manufactures and markets innovative medical devices for the treatment of vascular diseases. Current products are the world's first pro-healing stent, the Genous Stent, as well as other stents and balloons marketed under the names of Azule™, R stent, Scoreflex™, Sapphire™, Sapphire II and Sapphire NC. Development stage products include the Combo™ Bio-engineered Sirolimus Eluting Stent, or Combo Stent, which combines the Genous pro-healing technology for rapid endothelial coverage with an abluminal sirolimus drug elution for the control of neointimal proliferation. OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; and Tokyo, Japan. OrbusNeich, which has provided medical devices to physicians through its predecessor companies since 1979, supplies products today to interventional cardiologists in more than 60 countries. For more information, visit www.OrbusNeich.com.