SEOUL, South Korea, April 29 /PRNewswire/ -- OrbusNeich today announced that a subset analysis of patients over 70 years of age in the final 12-month clinical results of the global e-HEALING Registry confirmed that the company's Genous Bio-engineered R stent is safe and demonstrates excellent clinical outcomes in this high-risk patient group.
The data were presented by Dr. Andres Iniguez, M.D., of the Hospital Universitario de Vigo in Vigo, Spain, at the Angioplasty Summit Transcatheter Cardiovascular Therapeutics Conference Asia Pacific (TCTAP) 2010 in Seoul, South Korea.
The subset analysis evaluated 1,567 patients with a mean age of 75 years old from the e-HEALING clinical study and found a composite hierarchical major adverse cardiac event (MACE) rate of 9.9 percent with no Q-wave myocardial infarction (MI) at 12 months. The target lesion revascularization (TLR) rate was 6.7 percent, and the rate of target vessel failure (TVF) was 10.4 percent at 12 months. Per Academic Research Consortium (ARC) definition, the definite and probable subacute thrombosis (SAT) rate at 12 months was 0.9 percent, and the rate of late stent thrombosis (LST) was 0.3 percent.
Of the 1,063 male (67.8%) and 504 female (32.2%) patients, 39 percent had a prior acute myocardial infarction. Of the 2,169 lesions treated in the patient subset, 54.5 percent were type B2 or C. The study protocol recommends that patients receive one month of dual antiplatelet therapy post index procedure.
"Elderly patients represent an important segment of individuals undergoing PCI procedures," said Dr. Iniguez, the presenter of the study. "We are especially pleased to see excellent clinical outcomes in this high-risk patient subset for whom long-term dual antiplatelet therapy is not ideal. Elderly patients often require medication and non-cardiac surgery that can interfere with the post PCI standard of care. The Genous Bio-engineered R stent compares favorably to most DES registries without necessitating long-term dual antiplatelet therapy."
Al Novak, OrbusNeich's chairman and CEO, added, "Elderly patients are a challenging subset that often displays several co-morbidities and frequently benefits from a shorter course of dual antiplatelet therapy. This study confirms that the Genous Bio-engineered R stent is both an effective and safe treatment alternative that can satisfy the special needs of these older patients."
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 accelerates the natural healing process of the vessel wall after stent implantation. The technology consists of an antibody surface coating that captures EPCs circulating in the blood, which form a functional 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 6,000 patients in 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™, Sapphire™, Sapphire NC, 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.
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