HONG KONG, Feb. 11 OrbusNeich today announced that the first patient has been enrolled in a randomized clinical trial of the Genous Bio-engineered R stent in China.
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A multicenter, randomized, controlled study, the trial will enroll 180 patients split evenly between the control and test arms at 11 sites countrywide. The primary study objective is to demonstrate the safety and effectiveness of the Genous Bio-engineered R stent compared to the Medtronic Endeavor Sprint stent.
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The study population will consist of patients ages 18 to 75 with symptoms of angina or myocardial ischemia. The primary endpoints are difference in Major Adverse Cardiac Event (MACE) rates between the two groups at 12 months following implant and 270 day angiographic Late Loss (LL). Secondary endpoints include all-cause and cardiac mortality, myocardial infarction, in-stent thrombosis, MACE rates at 30, 60, 90, 180 and 270 days, as well as clinically driven Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR) and Target Lesion Failure (TLF) rates at 30, 60, 90, 180, 270 and 360 days.
The first patient was enrolled in the study at Beijing Chaoyang Hospital on December 8, 2009.
"We believe that the Genous Bio-engineered R stent will provide an excellent treatment option to patients who present challenging cases with standard drug eluting stents," said Prof. Lu Shuzheng from Anzhen Hospital, principal investigator of the trial.
Al Novak, OrbusNeich's chairman and CEO, added, "We are excited to take the Genous Bio-engineered R stent into this pivotal trial in China. We expect that clinical data from this study will show positive benefits for patients, including those who often encounter challenges with today's drug eluting stents."
About Genous
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.
OrbusNeich's Genous Bio-engineered R 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.
About OrbusNeich
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 Bio-engineered R stent, as well as stents, balloons and guiding catheters marketed under the names of Blazer(TM), R stent, Scoreflex(TM), SafeCut(TM), Sapphire(TM), Sapphire NC, Avita(TM), Avita HP and Lumina(TM). OrbusNeich is headquartered in Hong Kong and has operations in Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; Tokyo, Japan; and Shenzhen, China. 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.
SOURCE OrbusNeich
