HONG KONG, Oct. 11 /PRNewswire/ — OrbusNeich today reported the
completion of patient enrollment in a randomized clinical study of
its Genous Bio-engineered R stent at 11 sites in China.
The primary objective of the 180 patient, controlled study is to
demonstrate the safety and effectiveness of the Genous
Bio-engineered R stent compared to the Medtronic Endeavor®
Sprint stent in patients 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
after implantation and 270 day angiographic Late Loss (LL).
Patients enrolled in the study were split evenly between the
control and test arms.
“Based on its unique design and healing technology, we believe
that Genous has the potential to give physicians an additional
option for treating patients,” said Prof. Lu Shuzheng from Anzhen
Hospital, principal investigator of the trial. “We are excited to
complete enrollment in this study, which may bring further clinical
support for the technology’s use in China.”
David Chien, vice chairman of OrbusNeich, added, “This first
clinical study of Genous in China is significant in the full
development of the technology. We look forward to seeing additional
clinical support for the use of Genous in challenging cases, such
as diabetic patients and those who cannot tolerate a year of dual
antiplatelet therapy.”
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.
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
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