PARIS, May 26 /PRNewswire/ -- OrbusNeich today announced that 12-month follow-up data from a subset analysis of the global e-HEALING registry demonstrate that the company's Genous Bio-engineered R stent is effective in diabetic patients.
Peter Damman, M.D., of the Academic Medical Center in Amsterdam presented the subset analysis from 1,236 diabetic patients, including 273 insulin dependent diabetics (IDD) and 963 non-insulin dependent diabetics (NIDD), from the e-HEALING clinical registry and found a target vessel failure (TVF) rate of 10 percent for diabetic patients, compared to 7.9 percent for non-diabetics at 12 months. Specifically, the TVF rate in IDD was 13.4 percent, compared to 9 percent in NIDD. The higher TVF rates in diabetic patients were mainly driven by a higher mortality hazard. The target lesion revascularization rate (TLR) was 6.4 percent in diabetics, which is comparable to a reported 5.4 percent in non-diabetic patients, and the definite or probable stent thrombosis rate at 12 months was similar with 1.2 percent in diabetics compared to 1.1 percent in non-diabetics.
"The Genous Bio-engineered R stent shows positive clinical outcomes in diabetic patients who have a high prevalence of co-morbidities," said Prof. Robbert de Winter, M.D., Ph.D., of the Academic Medical Center in Amsterdam and a co-principal investigator of the study. "We see in the data that the stent thrombosis in all diabetic patients was comparable to non-diabetics. The growing prevalence of diabetes worldwide underscores the need for advanced treatment options for this challenging high-risk patient group."
The main composite outcome of the diabetic sub-study was TVF, defined as target vessel-related cardiac death or myocardial infarction (MI) and target vessel revascularization. The mean age of the e-HEALING diabetic population was 64 years, and the mean body mass index of patients was 28.3. Seventy-three percent of patients were male. An average of 1.4 lesions per patient were treated with an average of 1.1 stents. For the lesions treated, 97 percent were de novo lesions, and 48 percent were type B2/C lesions.
Michael Kutryk, M.D., Ph.D., clinician scientist and an interventional cardiologist at St. Michael's Hospital as well as an assistant professor at the University of Toronto, added, "The endothelial progenitor cells (EPCs) of diabetics exhibit an impaired capacity for vascular repair. The dysfunctional homing and adhesive abilities of EPCs of diabetics result in delayed endothelialization and subsequent heightened smooth muscle cell proliferation, leading to higher restenosis rates in diabetics. We believe that the unique EPC capture technology of the Genous Bio-engineered R stent mitigates these deficiencies and restores the natural healing ability that is impaired in diabetics."
e-HEALING is a multi-center, worldwide (outside of the United States) prospective clinical registry conducted in 31 countries at 144 clinical centers.
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.
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™, R stent, Scoreflex™, SafeCut™, Sapphire™, Sapphire NC, Avita™, Avita HP and Lumina™. 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.
Editor's Note: OrbusNeich is displaying the Genous Bio-engineered R stent at booth N06, Level 1, at EuroPCR 2010.