Other Presentations Highlight Pre-clinical Work of Company’s Future Pro-healing Technologies.
OrbusNeich announced today that two year follow up data from a single center, randomized clinical study in patients at high risk of restenosis were presented at EuroPCR 2009, demonstrating stable results in patients treated with the company’s Genous Bio-engineered R stent, the world’s first pro-healing stent, compared with results from patients treated with a drug-eluting stent.
Presented by Marcel Beijk, M.D., of the Academic Medical Center in Amsterdam, two year follow up data from the single center TRIAS HR (high risk) study show similar mortality (5.1% vs 4.2%) and target lesion revascularization (TLR) rates (15.3% vs 13.7%) for the Genous Bio-engineered R stent compared to Boston Scientific’s Taxus® Liberte stent in high risk of restenosis patients. However, the thrombosis rate for Taxus treated patients increased from one to two years from 4.2% to 5.3%, with another event occurring at 658 days in a patient who had previously presented with a subacute thrombosis and who was on dual antiplatelet therapy at the time of both thromboses. There were no thrombotic events in the Genous treated group at any time period (0.0%). Myocardial infarctions (MI) increased from years one to two in the Taxus patients to 6.3%, while the MI rate in the Genous patients remained steady at 3.1%, all of which were peri-procedural.
“While both groups of patients showed good clinical outcomes, the Genous treated patients were relatively stable between one and two years,” said Beijk.
TRIAS HR is a randomized, 193-patient, single-center, prospective study involving patients with a high risk of restenosis. High risk of restenosis is defined as patients who have diabetes mellitus and/or small vessels (less than or equal to 2.8 mm) and/or long lesions (greater than or equal to 23 mm) and/or chronic total occlusions. Two year follow up was obtained in all patients, with the exception of one.
The next generation of pro-healing stent technologies was highlighted in separate presentations, one focusing on pre-clinical results of an endothelial cell capture (EPC) surface on an abluminal, low dose sirolimus eluting stent (pro-healing SES), the other focusing on the company’s bioabsorbable stent developments.
Greg Kaluza, M.D., Ph.D., Director of Operations at the Jack H. Skirball Center for Cardiovascular Research in New York, presented the pro-healing SES’s pre-clinical results from multiple models supporting the soon to be initiated first in human study. The pro-healing SES demonstrated significantly lower neointimal hyperplasia, while also showing improved endothelial coverage relative to two other commercially available DES. There was also a noticeably lower presence of inflammation and foreign body reaction. “These data are remarkably promising across all criterion,” said Kaluza. “For the first time, a DES appears effective at inhibition of neointima while enhancing endothelial coverage early on.”
Development of the company’s bioabsorbable stent program was presented by Robert Cottone, vice president of intellectual property and technologies. Angiographic and optical coherence tomography (OCT) imagery were reviewed illustrating the new stent platform’s deliverability, design features, and vessel scaffolding. “The nature of the polymeric materials allows for tremendous innovation in stent design and functionality,” said Cottone. “With this new platform, combined with our coating technologies, we will be able to achieve clinical vascular restoration therapies simply not possible with metal.”
Unlike drug-eluting stents, Genous, which is coated with an antibody, captures a patient’s EPCs to accelerate the natural healing process. EPCs circulate in the bloodstream and are involved in the repair of blood vessels. When attracted to the surface of Genous, EPCs rapidly form an endothelial layer over the stent, providing a safe and effective alternative to DES.
OrbusNeich designs, develops, manufactures and markets innovative medical devices for the treatment of vascular diseases. Other products in the company’s product portfolio are stents, balloons and guiding catheters marketed under the names of Blazer™, R stent, Scoreflex™, SafeCut™, Sapphire™, Sapphire NC, Avita™, Avita HP, and Lumina™.
A global company, OrbusNeich is headquartered in Hong Kong and has operations in Fort Lauderdale, FL; Hoevelaken, The Netherlands; Tokyo, Japan; and Shenzhen, China. OrbusNeich, which has provided cardiology devices to physicians through its predecessor companies since 1979, today supplies products to interventional cardiologists in more than 60 countries. For more information, visit www.orbusneich.com.