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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

s showed a low TLR rate of 4.6 percent, a per protocol SAT and late thrombosis rate of 0.9 percent, and a MACE rate of 8.9 percent.

"The MACE rate is only 1.2 percent higher than the full cohort of the study and was mainly driven by mortality," said de Winter. "We expect a higher mortality rate in diabetic patients due to other comorbidities."

e-HEALING is a multi-center, worldwide (outside the United States) prospective clinical study conducted in 31 countries at 144 clinical centers. In addition to 25 percent of patients having diabetes mellitus, 42.4 percent of the patients had unstable angina and 11 percent had pre-procedure thrombus. For the lesions treated, 49.3 percent were type B2 or C. The study protocol recommends that patients receive one month of clopidogrel treatment after the index procedure. The primary endpoint of the study is target vessel failure at 12 months. The advanced electronic data capture via the internet with built in consistency checks for data monitoring was conducted by KIKA Clinical Solutions, a leading provider of advanced EDC solutions for clinical trials. Cardialysis, an independent Contract Research Organization (CRO), ensured quality, consistency and completeness of the data through comprehensive data management and monitoring.

Sigmund Silber, M.D., F.A.C.C., F.E.S.C., a professor of medicine with the Cardiology Practice and Hospital, Munich, and co-principle investigator, said, "Physicians rely on evidence-based recommendations for coronary interventions, and results from multicenter studies are more meaningful than those from a single center. The results from the large, multicenter e-HEALING study demonstrate the safety and efficacy of the Genous Bio-engineered R stent in a broad patient population - including remarkable outcomes for diabetic patients. This patient population shows a similar clinical outcome at 12-month follow-up compared to the total e-HEALING cohort,
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