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OrbusNeich's Combo Dual Therapy Stent™ Demonstrates Favorable Clinical and Safety Outcomes at 12-Month Follow-Up
Date:5/15/2012

dpoint was non-inferiority based on in-stent late lumen loss at nine months.  The in-stent late lumen loss for the Combo Stent was 0.39 +/- 0.45 mm, compared to 0.44 +/- 0.56 mm for the TAXUS stent. The results were presented late last year during the Late Breaking Clinical Trials and First Report Investigations Session at Transcatheter Cardiovascular Therapeutics (TCT) 2011 in San Francisco. The study's secondary endpoints included clinically driven TLR, binary restenosis, major adverse cardiac events (MACE) and ST rates, as well as all-cause and cardiac mortality, MI and TLF at 30 days, nine months and one through five years.

Ulf Landmesser, M.D., Ph.D., professor of cardiology and head of acute and co-head of invasive cardiology at the Cardiovascular Center, University Hospital of Zurich presented the study design for the REMEDEE OCT trial.

The REMEDEE OCT study will assess vascular healing after deployment of the Combo Stent in patients with acute coronary syndrome (ACS) with single de novo native coronary artery lesions ranging in diameter from greater than or equal to 2.5 mm to less than or equal to 3.5 mm and less than or equal to 20 mm in length. The REMEDEE OCT study, a prospective, multicenter, randomized study, will enroll 60 patients with ACS who will be randomized 1:1 to be treated with the Combo Stent versus the commercially available everolimus eluting stent. The primary endpoint of the study is the percentage of uncovered stent struts per stent at 60 days post procedure determined by OCT. Secondary clinical endpoints include stent thrombosis and major adverse cardiac events (MACE) at 30, 60, 180, 360 and 540 days. MACE is defined as a composite of death, myocardial infarction (MI), emergent coronary artery bypass surgery (CABG), or justified target lesion revascularization (TLR).

"Currently, 55 patients have been enrolled in the REMEDEE OCT study, and we anticipate to complete the enrollment in the next couple of
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