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Final 12 Month Clinical Data from 5,000 Patients in Worldwide e-HEALING Clinical Study Show Good Safety and Efficacy with Real World Use of OrbusNeich's Genous(TM) Bio-engineered R stent(TM)
Date:9/22/2009

SAN FRANCISCO, Sept. 22 /PRNewswire/ -- OrbusNeich today announced that the final 12-month clinical data from the global e-HEALING clinical study showed that the company's Genous Bio-engineered R stent is safe and effective in real world use, including in the treatment of patients with diabetes mellitus.

The study evaluated 4,987 of the 4,996 enrolled patients and found a target vessel failure (TVF) rate of 8.1 percent at 12 months with a follow-up rate of 92 percent, a target lesion revascularization (TLR) rate of 4.4 percent, a major adverse cardiac events (MACE) rate of 7.7 percent, a subacute thrombosis (SAT) rate of 0.5 percent and a late stent thrombosis (LST) of 0.3 percent. The combined SAT and late thrombosis rate of 0.8 percent was per protocol. Per Academic Research Consortium (ARC) definition, the definite and probable SAT and late thrombosis rate is 1.0 percent. The data were presented by Professor Robbert de Winter, M.D., Ph.D., of the Academic Medical Center in Amsterdam at the Transcatheter Cardiovascular Therapeutics symposium, TCT 2009, in San Francisco.

"The excellent study design, electronic data capture and monitoring as well as comprehensive data management resulted in robust data for the e-HEALING clinical study, which further supports the efficacy and safety of the Genous Bio-engineered R stent," said de Winter, a co-principal investigator of the study. "We are especially pleased to see positive results in certain subsets of patients, such as diabetic patients, which often present as challenging cases with an expected higher incidence of in-stent-restenosis."

Twenty five percent of the patients in the study had diabetes mellitus. In a poster presentation, also at TCT 2009, de Winter and colleagues reported data from an analysis of this subset of the e-HEALING study. The 12-month follow-up from these 1,243 patients with diabetes mellitu
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