Unique Studies with Orbus Neich's Genous(TM) Stent Further Validate Early Endothelial Progenitor Cell Coverage and Reduced Thrombogenicity in Human Circulating Blood Compared to Bare Metal Stents
Published: Nov 23, 2010
Eric J. Duckers, M.D., Ph.D., of the Thoraxcenter at Erasmus University Medical Center in Rotterdam, The Netherlands, and co-investigators Saami Yazdani, Ph.D., and Renu Virmani, M.D., of the CVPath Institute Inc., in Gaithersburg, Md., presented collaborative data last week at the American Heart Association's Scientific Sessions 2010 that demonstrated the mechanism of early EPC capture and reduced thrombogenicity of the Genous Stent in human circulating blood in an ex vivo arteriovenous shuntmodel.
The data showed that the Genous Stent bound significantly more cells and had markedly less thrombus than BMS. Gene expression analysis showed that endothelial specific markers were significantly increased and thrombogenic markers were significantly decreased with the Genous Stent compared to BMS.
"These data demonstrate the importance of CD34+ cells for endothelialization and the prevention of thrombosis," said Dr. Duckers. "This mechanism of early endothelization supports the design of the unique EPC capture technology of Genous."
Before analysis, the stents were implanted in an arteriovenous shunt in 10 patients for up to two hours during which patients underwent elective percutaneous coronary intervention (PCI). One subset of stents was analyzed at CVPath Institute by scanning electron microscopy followed by semi-quantitative determination of cell coverage and thrombus area. A second set of stents was also subjected to quantitative real time polymerase chain reaction (qPCR ) analysis to determine gene expression of endothelial and thrombogenic markers in the attached cells.
The data comparing the Genous Stent and BMS were further validated in an in vitro coronary artery model infused with human peripheral blood CD34+ cells and human monocytes. The in vitro study demonstrated a higher affinity of CD34+ cells, which are associated with endothelialization, and a lower adhesion of monocytes, which are associated with inflammation, to the Genous Stent compared to BMS.
"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 Dr. Virmani. "The Genous Stent appears to not only promote the adhesion of human EPCs, but also reduces the adhesion of fibrin, platelets and inflammatory cells, which is important for the prevention of thrombus."
In a second study, increased cell coverage was observed for the Genous Stent compared to BMS in vivo. The study, carried out in rabbits, further showed the increased expression of endothelial specific genes for the Genous Stent compared to BMS. The study was designed to investigate the gene expression patterns of endothelial specific genes and endothelial coverage by scanning electron microscopy and qPCR after stents were implanted in carotid arteries for seven days.
"The data presented for each experimental model represent the mechanistic validation for our Genous Stent," said Steve Rowland, OrbusNeich's vice president of research and development. "This is further evidence that the technology behind the Genous Stent accelerates the healing of the vessel wall and provides an important alternative to those patients with a high risk for thrombosis."
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.
The Genous Stent has been commercially available in over 60 countries since 2005. The Genous Stent has been proven as a safe, effective alternative to drug-eluting stents and is supported by data from more than 5,000 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 stents, balloons and guiding catheters marketed under the names of Blazer, R stent, Scoreflex, Sapphire 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.
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