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Long Term Data Presented at EuroPCR 2009 from Randomized Study Attest to Durability of Results of OrbusNeich's Genous(TM) Bio-engineered R stent(TM) Compared to Drug-Eluting Stents
Date:5/20/2009

Other Presentations Highlight Pre-clinical Work of Company's Future Pro-healing Technologies

BARCELONA, Spain, May 20 /PRNewswire/ -- OrbusNeich announced today that two year follow up data from a single center, randomized clinical study in patients at high risk of restenosis were presented at EuroPCR 2009, demonstrating stable results in patients treated with the company's Genous Bio-engineered R stent, the world's first pro-healing stent, compared with results from patients treated with a drug-eluting stent.

Presented by Marcel Beijk, M.D., of the Academic Medical Center in Amsterdam, two year follow up data from the single center TRIAS HR (high risk) study show similar mortality (5.1% vs 4.2%) and target lesion revascularization (TLR) rates (15.3% vs 13.7%) for the Genous Bio-engineered R stent compared to Boston Scientific's Taxus(R) Liberte stent in high risk of restenosis patients. However, the thrombosis rate for Taxus treated patients increased from one to two years from 4.2% to 5.3%, with another event occurring at 658 days in a patient who had previously presented with a subacute thrombosis and who was on dual antiplatelet therapy at the time of both thromboses. There were no thrombotic events in the Genous treated group at any time period (0.0%). Myocardial infarctions (MI) increased from years one to two in the Taxus patients to 6.3%, while the MI rate in the Genous patients remained steady at 3.1%, all of which were peri-procedural.

"While both groups of patients showed good clinical outcomes, the Genous treated patients were relatively stable between one and two years," said Beijk.

TRIAS HR is a randomized, 193-patient, single-center, prospective study involving patients with a high risk of restenosis. High risk of restenosis is defined as patients who have diabetes mellitus and/or small vessels (less than or equal to 2.8 mm) and/or long lesions (greater than or equal to 23
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