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OrbusNeich's Genous™ Bio-engineered R stent™ Shows Favorable Safety Profile and Clinical Outcomes in Combination with Paclitaxel-Coated Balloon for De Novo Coronary Artery Disease
Date:9/23/2010

WASHINGTON, Sept. 23 /PRNewswire/ -- OrbusNeich today announced that six-month follow-up clinical trial data demonstrate the excellent safety profile and efficacy of the company's Genous Bio-engineered R stent in combination with a paclitaxel-coated balloon for the treatment of de novo coronary artery disease. The data were presented by Jochen Woehrle, M.D., University of Ulm, Germany, principal investigator of the study, in the first report clinical trial session at Transcatheter Cardiovascular Therapeutics (TCT) 2010 in Washington.

The PERfECT STENT (A Prospective, Randomized Trial Evaluating a Paclitaxel-Eluting Balloon in Patients Treated with Endothelial Progenitor Cell Capturing Stents for De Novo Coronary Artery Disease) study compared the combination of a paclitaxel-coated balloon (SeQuent® Please, B. Braun) with a Genous stent to the Genous stent alone in 120 patients undergoing percutaneous coronary intervention (PCI).

The primary endpoint of the study was in-stent late loss at six months. Secondary endpoints included diameter stenosis, binary restenosis rate, target lesion revascularization (TLR), major adverse cardiac events (MACE) and stent thrombosis.

The in-stent late loss at six months follow-up of 0.34 mm was significantly lower in the patient group treated with the Genous stent in combination with a paclitaxel-coated balloon when compared to 0.88 mm in the control group. There was no definite and probable stent thrombosis reported in either arm of the study. Both patient groups received three months of dual antiplatelet therapy. In addition, the rates of TLR and MACE were lower in the investigational group compared to the control group.

"We are very encouraged by the good clinical and safety outcomes seen in patients treated with a combination of a paclitaxel-coated balloon and pro-healing technologies with only three months of dual antiplatelet therapy," said Professor Woehrle. "This study supports the company
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