SAN FRANCISCO, Nov. 9, 2011 /PRNewswire/ -- OrbusNeich today announced that the company's Genous Stent provides the most rapid healing of the coronary vessel compared with bare metal stents and drug eluting stents (DES) at 14 days post-implantation. The data were presented by Ladislav Groch, M.D., of the University Hospital St. Anna, Brno, Czech Republic, in the Featured Clinical Research II session at Transcatheter Cardiovascular Therapeutics (TCT) 2011 in San Francisco.
The prospective, single-center, randomized study compared the endothelial stent coverage of the Blazer™ Cobalt Chromium Stent, the cobalt chromium SolarFlex stent and the biolimus eluting coronary stainless steel Nobori® stent with the Genous Stent, measuring optical coherence tomography (OCT) at 14 days. The percentage of healed struts – a proxy for endothelial coverage, the most powerful predictor of stent thrombosis – was significantly higher in the Genous Stent compared to the analyzed cobalt chromium stents and the DES. Specifically, the Genous Stent had 69.7 percent healed and 5.3 percent malapposed struts compared to 56.7 percent healed and 19.7 percent malapposed struts for the Blazer Stent, 55.2 percent healed and 13.9 percent malapposed struts for the SolarFlex stent and 34 percent healed and 45.7 percent malapposed struts for the Nobori stent.
"These data confirm that the endothelial progenitor cell-capturing Genous Stent accelerates the healing of the coronary vessel wall following percutaneous coronary intervention relative to bare metal stents and DES," said Dr. Groch. "Early healing is a powerful predictor of subacute and late stent thrombosis, and the high percentage of covered struts seen with the Genous Stent potentially minimises the length of dual antiplatelet therapy. This is especially important for patients with an increased risk for bleeding."
The primary endpoint of the study was the percentage of covered struts. Secondary endpoints were the percentage of malapposed struts and the absolute thickness of neointima. The study included 40 patients with stable or unstable angina or non-sustained myocardial infarction (MI) who underwent percutaneous coronary intervention with stent implantation; a total of 44 stents were implanted. The patients were randomized into four groups with 10 patients per group, and a total of 4413 stent struts were analyzed manually.
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, 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 7,000 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™ Dual Therapy Stent, the only dual therapy stent to both accelerate endothelial coverage and control neo-intimal proliferation through the combination of the Genous pro-healing technology with an abluminal sirolimus drug elution. OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; and Tokyo, Japan. OrbusNeich supplies medical devices to interventional cardiologists in more than 60 countries. For more information, visit www.OrbusNeich.com.
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