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REMEDEE Study Meets Primary Endpoint: OrbusNeich's Combo™ Dual Therapy Stent Is Non-Inferior to DES
Date:11/14/2011

HONG KONG, Nov. 14, 2011 /PRNewswire/ -- OrbusNeich today announced that results from the REMEDEE study (Randomized Evaluation of an abluMinal sirolimus coatED bio-Engineered stEnt) confirmed that the Combo Dual Therapy Stent is non-inferior to the TAXUS® Liberte® paclitaxel-eluting stent, with respect to in-stent late lumen loss at nine-month angiographic follow-up. The results were presented by Michael Haude, M.D., director of Medical Clinic I at the Lukaskrankenhaus in Neuss, Germany, last week during the Late Breaking Clinical Trials and First Report Investigations Session at Transcatheter Cardiovascular Therapeutics (TCT) 2011 in San Francisco.

The Combo Stent, the world's first dual therapy stent (DTS), combines an abluminal biodegradable sirolimus elution for the regulation of hyperplasia with Genous™, OrbusNeich's proven endothelial progenitor cell (EPC) capture technology, to accelerate re-endothelialization. The study's primary objective was to demonstrate the safety and effectiveness of the Combo Stent compared to the TAXUS Liberte paclitaxel-eluting stent in patients with symptomatic, ischemic heart disease due to a stenotic lesion located in a native coronary artery. The study's primary endpoint was non-inferiority based on in-stent late lumen loss at nine months.

At nine-month angiographic follow-up, the in-stent late lumen loss for the Combo Dual Therapy Stent was 0.39 +/- 0.45 mm compared to 0.44 +/- 0.56 mm for the TAXUS drug eluting stent (DES).

"This first clinical experience with the Combo Dual Therapy Stent confirms that Combo achieves an antiproliferative effect and safety profile similar to that of current DES," said Prof. Haude. "However, the real differentiating factor for Combo is the Genous pro-healing technology. Using intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging, we saw superb homo
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