PARIS, May 15, 2012 /PRNewswire/ -- OrbusNeich today announced that 12-month follow-up data from the REMEDEE study showed favorable clinical and safety outcomes involving the use of the company's Combo Dual Therapy Stent when compared to the TAXUS® Liberte® paclitaxel-eluting stent. The data were presented by Michael Haude, M.D., of Medical Clinic I at the Lukaskrankenhaus in Neuss, Germany, at EuroPCR 2012.
In the 12-month follow-up data set, the clinically driven target lesion failure (TLF) rate was 8.9% for patients treated with the Combo Stent, compared to 10.2% for those treated with the TAXUS stent. Clinically driven TLF was defined as a composite of death, myocardial infarction (MI) and clinically driven target lesion revascularization (TLR). In addition, the rate of clinically driven TLR was 4.9% for patients treated with the Combo Stent, compared to 8.5% for those treated with the TAXUS stent. There was no stent thrombosis (ST) in either of the groups.
"The in-stent and in-segment late loss and binary restenosis rates were accordingly low for the Combo Stent and comparable to those of the TAXUS stent," said Prof. Haude. "Additionally, we saw a uniform, homogeneous neointimal response with the Combo Stent, compared to the more heterogeneous and layered neointimal tissue appearance with the TAXUS stent. Other data are being presented this week, and we look forward to presenting two-year follow-up and other results of the REMEDEE study at upcoming conferences."
REMEDEE (Randomized Evaluation of an abluMinal sirolimus coatED bio-Engineered stEnt) is a randomized clinical trial designed to demonstrate the safety and efficacy of the Combo Dual Therapy Stent compared to the TAXUS 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. 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 weeks," said Prof. Landmesser. "The data will be presented at a conference later this year."
About the Genous Technology
Genous is OrbusNeich's patented EPC capture technology that promotes the accelerated natural healing of the vessel wall after the implantation of blood-contact devices such as stents. The technology consists of an antibody surface coating that attracts EPCs circulating in the blood to the device to form an endothelial layer that provides protection against thrombosis and modulates restenosis.
The Genous Stent, which has been commercially available in more than 60 countries since 2005, has been proven as a safe, effective alternative to drug eluting stents and is supported by data from more than 7,000 patients in clinical studies. There is a growing body of evidence from multiple clinical studies that the Genous Stent is effective for patients that are non-responsive to or cannot tolerate long-term dual antiplatelet therapy.
OrbusNeich is a global company that designs, develops, manufactures and markets innovative medical devices for the treatment of vascular diseases. Current products are the world's first pro-healing stent, the Genous Stent, as well as other stents and balloons marketed under the names of Azule™, R stent, Scoreflex™, Sapphire™, Sapphire II and Sapphire NC. Development stage products include the Combo Dual Therapy Stent, the only dual therapy stent to both accelerate endothelial coverage and control neointimal proliferation through the combination of the Genous pro-healing technology with an abluminal sirolimus drug elution delivered from a biodegradable polymer that achieves full and complete dissipation by 90 days. OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; and Tokyo, Japan. OrbusNeich supplies medical devices to interventional cardiologists in more than 60 countries. For more information, visit www.OrbusNeich.com.
Note: OrbusNeich will display its stents at booth N6 at EuroPCR 2012.
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