, Sept. 24
/PRNewswire/ -- OrbusNeich today announced at the Transcatheter Cardiovascular Therapeutics (TCT) 2010 in Washington
the completion of patient enrollment in the randomized clinical trial of the Combo Bio-engineered Sirolimus Eluting Stent (Combo Stent) with 183 patients included at sites in Asia
and South America
"Completion of enrollment of this study represents a significant milestone as we look to validate the potential for the Combo Stent in a clinical setting," said Al Novak, Chairman and CEO of OrbusNeich.
The primary objective of the prospective, randomized, multicenter study, called REMEDEE (Randomized Evaluation of an abluMinal sirolimus coatED bio-Engineered stEnt), is to demonstrate 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. This objective will be measured in patients by a comparison of in-stent late lumen loss at nine months post-procedure.
Michael Haude, M.D., director of Medical Clinic I at the Lukaskrankenhaus in Neuss, Germany, and one of the trial's principal investigators, added, "The Combo Stent has the potential to bring a unique treatment option to physicians by combining the proven Genous endothelial progenitor cell capture technology with a low dose sirolimus elution. Because the pre-clinical data demonstrate lower neointimal hyperplasia and improved endothelial coverage, we look forward to obtaining clinical confirmation of the results."
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 lesions treated are 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 concept and design of the Combo Stent can provide a safe alternative for patients with a high risk of restenosis," said Alexandre Abizaid, M.D., Ph.D., director of the catheterization laboratory at the Institute Dante Pazzanese of Cardiology in Sao Paulo, Brazil, and a principal investigator of the study. "We look forward to obtaining data from the REMEDEE study to determine the Combo Stent's potential."
The Combo Stent is designed to combine the pro-healing technology used in OrbusNeich's Genous Bio-engineered R stent for rapid endothelial coverage with an abluminal sirolimus drug elution for the control of neointimal proliferation.
Genous is OrbusNeich's patented endothelial progenitor cell (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.
OrbusNeich's Genous Bio-engineered R stent has been commercially available in over 60 countries since 2005. The Genous stent has been proven as a safe, effective alternative to drug-eluting stents and is supported by data from more than 5,000 patients in company-sponsored clinical studies. There is a growing body of evidence from multiple clinical studies that the Genous stent is effective for patients who 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 Bio-engineered R stent, as well as stents, balloons and guiding catheters marketed under the names of Blazer, R stent, Scoreflex, Sapphire and Sapphire NC. Development stage products include the Combo Bio-engineered Sirolimus Eluting Stent, or Combo Stent, which combines the Genous pro-healing technology for rapid endothelial coverage with an abluminal sirolimus drug elution for the control of neointimal proliferation. OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; and Tokyo, Japan. OrbusNeich, which has provided medical devices to physicians through its predecessor companies since 1979, supplies products today to interventional cardiologists in more than 60 countries. For more information, visit www.OrbusNeich.com.