SAN FRANCISCO, Nov. 8, 2011 /PRNewswire/ -- OrbusNeich today announced that three-year clinical outcomes data from the use of the Genous Stent in a large, real-world patient population demonstrate the device's long-term safety and efficacy. These results were published in the October issue of the Journal of Interventional Cardiology.
At three-year clinical follow-up, the study's primary endpoint, a composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR), in an unselected patient population was 18.3%. Between one and three years, TLR had increased by only 3.6%, and no cases of late and very late definite stent thrombosis (ST) were observed.
"This is the first report of three-year clinical outcomes for the Genous Stent, and it is important to recognize that only a small number of studies have ever reported on three-year outcomes following percutaneous coronary intervention with stent placement in an all-comer population," said Margo Klomp, M.D., of the Academic Medical Center, Amsterdam, and lead author of the publication. "The target lesion failure rate of 18.3% in this case is on the lower end of the spectrum versus reported DES outcomes. In addition, late and very late ST was absent in our Genous Stent treated cohort, whereas other registries have reported occurrence of late and very late ST in DES treated patients."
The single-center study included 405 unselected patients with mostly complex lesions with an estimated high risk of restenosis. Specifically, 47% of the patients had multivessel disease, and, of the lesions treated, 75% were type B2/C lesions, 20% were chronic total occlusion (CTO) lesions, and 24% were bifurcated lesions. The average stent length was 24.6 +/- 11.7 mm. Patients were treated with clopidogrel for one month, and 16 patients received clopidogrel for less than one month. The duration of aspirin administration was indefinite.
"For patients treated with Genous, our typical prescription of dual antiplatelet therapy (DAPT) is 30 days," said Robbert de Winter, M.D., Ph.D., of the Academic Medical Center, Amsterdam. "In this large, unselected patient population, there was also a segment of patients who were contraindicated to long-term DAPT and thus received less than 30 days of DAPT. For this reason, it was particularly striking there were only two cases of early stent thrombosis and that no thrombosis was observed after one month through the three year follow up, attesting to the excellent safety profile of Genous in a real world setting."
Please visit the following link to hear Prof. de Winter discuss these data: http://youtu.be/qFLGkc2PaXg.
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 7,000 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™, 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 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.
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