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 Stent," said Dr. Thambar. "This innovative technology potentially represents the next generation of coronary stents."
The Combo Stent is designed to combine the pro-healing technology used in OrbusNeich's Genous(TM) Bio-engineered R stent(TM) for rapid endothelial coverage with an abluminal sirolimus drug elution for the control of neointimal proliferation. The low dose sirolimus elution is accomplished through the use of the SynBiosys(TM) biodegradable polymer matrix from SurModics, Inc. ( SRDX).
"The pre-clinical work has shown the effectiveness of combining the endothelial progenitor cell capture technology to promote endothelialization coupled with the low dose, abluminal sirolimus elution to regulate hyperplasia," said Ian T. Meredith, M.B.B.S., Ph.D., Professor of Cardiology, Director of MonashHeart and Executive Director of the Monash Cardiovascular Research Centre, Melbourne, Australia, one of the trial's principal investigators. The other principal investigators are Stephan Windecker, M.D., director of invasive cardiology at the University Hospital Bern in Switzerland, and Alexandre Abizaid, M.D., Ph.D., director of the catheterization laboratory at the Institute Dante Pazzanese of Cardiology in Sao Paulo, Brazil. "The Combo Stent could be the best of both world's approach for patients at the highest risk of restenosis," Meredith added.
"The Combo Stent has demonstrated significantly lower neointimal hyperplasia, improved endothelial coverage relative to commercially available drug-eluting stents and lower presence of inflammation and foreign body reaction in multiple pre-clinical studies," said Renu Virmani, M.D., president and medical director of CVPath Institute, Inc. "Furthermore, I have long believed that the next generation of stents can benefit from biodegradable polymers. The data I've seen on the SynBiosys biodegradable polymer suggest it is very biocompatible with low inflammatory scores that could also result in improved endothelialization."
"These are exciting times for our company," said Al Novak, OrbusNeich's president and CEO. "Final 12 months follow up data on a worldwide study of 5,000 patients treated with Genous establishes our pro-healing technology as an effective therapy. We fully expect the Combo Stent to build on this by expanding the potential applicability to those patients at highest risk of restenosis, without the longer term safety risks associated with today's drug eluting stents."
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(TM), R stent, Scoreflex(TM), SafeCut(TM), Sapphire(TM), Sapphire NC, Avita(TM), Avita HP and Lumina(TM). OrbusNeich is headquartered in Hong Kong and has operations in Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; Tokyo, Japan; and Shenzhen, China. 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.
For more information about REMEDEE, visit http://www.clinicaltrials.gov/ct2/show/NCT00967902?term=remedee&rank=1.
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