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OrbusNeich's Genous(TM) Bio-engineered R stent(TM) Demonstrates Excellent Safety and Clinical Outcomes in High-Risk Elderly Patients
Date:4/29/2010

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 excel
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