SINGAPORE, Jan. 23 OrbusNeich announced that clinical data presented today at Asia PCR/Singapore LIVE 2010 demonstrated the benefits of the Genous Bio-engineered R stent in the treatment of two challenging patient subsets.
Specifically, presentations delivered by Prof. Robbert de Winter, M.D., Ph.D., of the Academic Medical Center (AMC) in Amsterdam and Wojciech Wojakowski, M.D., from Medical University of Silesia in Poland focused on the use of the Genous Bio-engineered R stent in patients with bifurcation lesions and patients with non ST-segment elevation acute coronary syndrome.
Prof. de Winter's presentation, titled "One Year Clinical Outcome after Provisional T Stenting with the Endothelial Progenitor Cell Capturing Stent for Bifurcation Lesions," featured a single-center study with 178 patients that compared the Genous Bio-engineered R stent to a previous bare metal stent control group of 465 patients at the AMC. A 32 percent reduction of the composite of cardiac death, myocardial infarction or target lesion revascularization was reported between these two groups. The cumulative rate of definite or probable stent thrombosis was reduced by 57 percent in the Genous Bio-engineered R stent-treated group compared to the control group.
"Bifurcation lesions remain a challenge for interventional cardiologists," said Prof. de Winter. "The Genous Bio-engineered R stent, with a low rate of stent thrombosis, is an alternative for this challenging patient group."
Dr. Wojakowski presented data on the JACK-EPC trial, a comparison of the efficiency of high dose atorvastatin and endothelial progenitor-capture stents versus bare metal stents, in the reduction of neointimal formation in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS). The randomized study with 60 patients compared the Genous Bio-engineered R stent with bare metal stents with concomitant high dose atorvastatin in the reduction of neointimal hyperplasia assessed by coronary angiography and IVUS after six months.
In the JACK-EPC trial, the Genous Bio-engineered R stent induced less neointimal hyperplasia and a lower binary restenosis rate of 13 percent in the Genous Bio-engineered R stent, compared to 26.6 percent in the control group. Importantly, the major adverse cardiac events (MACE) rate was reported at only 10 percent in the Genous Bio-engineered R stent treated patient group versus 16 percent in the bare metal stent treated group.
"In our small study, we observed a lower amount of neointimal proliferation with the EPC capture stent compared to the bare metal stent control," said Wojakowski. "Good safety is indicated by comparable stent thrombosis. We think this makes the Genous stent a very promising treatment strategy for ACS patients, especially those with high risk of bleeding or not eligible for prolonged dual antiplatelet therapy due to allergy to ASA or clopidogrel."
"Data from both presentations support the use of the Genous Bio-engineered R stent as an effective treatment option in what interventional cardiologists find to be challenging cases," said Al Novak, OrbusNeich's chairman and CEO. "We look forward to continuing to work with physicians to realize the full potential of the Genous technology."
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.