Data From REMEDEE Trial Featuring OrbusNeich’s Combo(TM) Dual Therapy Stent to be Presented in Late Breaking Clinical Trials and First Report Investigations Session at TCT 2011
HONG KONG, Nov. 1, 2011 /PRNewswire/ — OrbusNeich today announced that data from REMEDEE (Randomized Evaluation of an abluMinal sirolimus coatED bio-Engineered stEnt), a randomized clinical trial of the Combo Bio-engineered Sirolimus Eluting Stent (Combo Dual Therapy Stent), will be presented in the Late Breaking Clinical Trials and First Report Investigations Session at TCT 2011 in San Francisco. The presentation entitled “REMEDEE: A Prospective, Randomized Trial of a Combination Bioabsorbalble Polymer-based Anti-CD34 Antibody Sirolimus-Eluting Stent vs. a Durable Polymer-based Paclitaxel-Eluting Stent” by Michael Haude, M.D., of Medical Clinic I at the Lukaskrankenhaus in Neuss, Germany, will take place at 11:10 a.m. PST on Nov. 11 in the main arena.
The REMEDEE trial was designed to demonstrate the safety and effectiveness of the Combo Dual Therapy Stent compared to the TAXUSÃ‚® LiberteÃ‚® paclitaxel-eluting stent in patients with symptomatic, ischemic heart disease due to a stenotic lesion located in a native coronary artery. This objective was measured in patients by a comparison of in-stent late lumen loss at nine months post-procedure. The trial included 183 patients at sites in Asia, Australia, Europe and South America.
On Thursday, Nov. 10, the Combo Dual Therapy Stent will be featured in a REMEDEE Breakfast Symposium titled “The New Combo Dual Therapy Stent.” The symposium will be chaired by Martin B. Leon, M.D., and Alexandre Abizaid, M.D., and will take place at 7 a.m. PST in room 120. The symposium will provide an overview of the stent’s underlying pro-healing technology, Genous, and the rationale of the REMEDEE study. Dr. Leon will introduce the new category of dual therapy stents, Roxana Mehran, M.D., will discuss the need for novel stents, Dr. Abizaid will describe the technology behind the Combo Dual Therapy Stent, and Michael Haude, M.D., will discuss the REMEDEE study design. Other presentations will include the OCT assessment of pro-healing stent coverage by Stephen W. L. Lee, M.D. Ulf Landmesser, M.D., and Mitchell W. Krucoff, M.D., will provide an overview about ongoing and relevant clinical investigations for the Combo Dual Therapy Stent.
Another presentation highlighting the Genous pro-healing stent technology is a talk entitled “A Prospective, Multicenter, Randomized Trial of the Early Healing of Four Types of Stents Assessed by Optical Coherence Tomography” by Ladislav Groch, M.D. This will take place at 7:45 p.m. PST on Tuesday, Nov. 8, in room 121.
About Combo Dual Therapy Stent
OrbusNeich’s Combo Dual Therapy Stent is the only dual therapy stent that accelerates endothelial coverage and controls neointimal proliferation. The Combo Dual Therapy Stent combines the pro-healing technology used in the Genous(TM) 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.
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 6,000 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 Stent, as well as other stents and balloons marketed under the names of Azule(TM), R stent, Scoreflex(TM), Sapphire(TM), 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 neo-intimal proliferation through the combination of the Genous pro-healing technology with an abluminal sirolimus drug elution. 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.
Editor’s Notes: OrbusNeich will display the Combo Dual Therapy Stent, the Genous Stent and other products at booth No. 1429 at TCT 2011. Product images are available on request.