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OrbusNeich Announces First Patient Enrolled in REMEDEE, a Randomized Clinical Trial of the Combo Bio-engineered Sirolimus Eluting Stent
Date:12/1/2009

FORT LAUDERDALE, Fla., Dec. 1 /PRNewswire/ -- OrbusNeich today announced the initiation of patient enrollment in the randomized clinical trial of the Combo Bio-engineered Sirolimus Eluting Stent (Combo Stent).

A prospective, randomized, multicenter study, REMEDEE (Randomized Evaluation of an abluMinal sirolimus coatED bio-Engineered stEnt) will enroll 180 patients at up to 20 sites in Asia, Australia, Europe and South America. The primary objective is to demonstrate the safety and effectiveness of the Combo Stent compared to the TAXUS® Liberte® paclitaxel-eluting stent (DES) in the treatment of single de novo native coronary lesions ranging in diameter from greater than or equal to 2.5 mm and less than or equal to 3.5 mm and less than or equal to 20 mm in length.

The study population will consist of patients with symptomatic, ischemic heart disease due to a stenotic lesion located in a native coronary artery. The primary endpoint is in-stent late lumen loss of the Combo Stent compared to DES at nine months post-procedure. Secondary endpoints include all-cause and cardiac mortality, myocardial infarction, Major Adverse Cardiac Event (MACE) and stent thrombosis rates at 30 days, nine months and one through five years, as well as clinically driven Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR) and Target Lesion Failure (TLF) rates at the same follow-up times.

The first patient enrolled in the REMEDEE study is a 48 year old male with a lesion located in the proximal left anterior descending artery. The stent was successfully inserted at John Hunter Hospital in Newcastle, Australia, by Dr. Greg Bellamy and Dr. Sukumaran Thambar. "We are pleased to be the initiating centre for this trial and to work with such a high caliber of experts to evaluate the clinical utility of the Combo St
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