-- Post-Market Registry to Evaluate Long-Term Safety and Performance in Routine Practice
HONG KONG, March 28, 2014 /PRNewswire/ -- OrbusNeich today announced the completion of enrollment in the prospective, multicenter, all-comers REMEDEE Registry (Multicenter, Prospective, Clinical Outcomes After Deployment of the Abluminal Sirolimus Coated Bio-Engineered Stent (Combo Bio-Engineered Sirolimus Eluting Stent) Post Market Registry) to evaluate the COMBO Stent for the treatment of coronary lesions in the setting of routine clinical care. The registry enrolled 1,000 patients at nine European high-volume percutaneous coronary intervention centers in France, Latvia, Luxembourg, The Netherlands, United Kingdom and Spain.
The registry's primary endpoint is clinically driven target vessel failure (TVF) at one year post procedure, which includes cardiac death, target vessel myocardial infarction (MI) and ischemia driven target vessel revascularization (TVR).
"The REMEDEE Registry will evaluate the long-term safety and performance for the COMBO Stent in a real-world patient population," said Robbert de Winter, M.D., Ph.D., of the Academic Medical Center, Amsterdam, and principal investigator of the study. "This innovative device allows for accelerated stent endothelialization and healing and therefore addresses the challenge of delayed arterial healing caused by monotherapy drug eluting stents. We expect primary endpoint data in the second quarter of 2015."
Secondary endpoints include device and procedural success and adjudicated target lesion failure (TLF) at 30 and 180 days post procedure. Additional secondary endpoints to be evaluated at 30, 180 and 365 days include the components of TVF, defined as cardiac death, target vessel MI and ischemia driven TVR; adjudicated major adverse cardiac events (MACE) as a composite and as each of its components, defined as death, any MI and any revascularization; and adjudicated stent thrombosis. Clinical follow-up will be conducted each year up to five years.
For more information about the REMEDEE Registry, please visit http://www.clinicaltrials.gov/ct2/show/NCT01874002.
About the COMBO Dual Therapy Stent
The COMBO Dual Therapy Stent is the first dual therapy stent to both accelerate endothelial coverage and control neo-intimal proliferation through the combination of the proven pro-healing technology with an abluminal sirolimus drug elution delivered from a biodegradable polymer that achieves full and complete dissipation by 90 days.
OrbusNeich's patented EPC capture technology 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 captures EPCs circulating in the blood to the device to form an endothelial layer that provides protection against thrombosis and modulates restenosis.
The COMBO Dual Therapy Stent has received CE Mark approval in Europe. The COMBO Stent is an investigational device and not available for sale in Japan and the U.S.
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 dual therapy stent, the COMBO Dual Therapy Stent, and the world's first pro-healing stent, the Genous™ Stent. Other products include stents and balloons marketed under the names of Azule™, R stent, Scoreflex™, Sapphire™, Sapphire II and Sapphire NC. 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.
Follow OrbusNeich on Twitter at www.twitter.com/OrbusNeich, and learn more about the company and its innovative technology on OrbusNeich's YouTube Channel: http://www.youtube.com/user/OrbusNeichMedia.