OrbusNeich announced today that pre-clinical data involving porcine coronary models demonstrate that the company's Combo Bio-engineered Sirolimus Eluting Stent (Combo Stent) may offer advantages to the Cypher(R) sirolimus eluting stent and the XIENCE(TM) V everolimus eluting stent.
Specifically, histological and optical coherence tomography (OCT) data out to 28 days show that the Combo Stent had lower neointimal hyperplasia and stenosis, as well as lower inflammation and fewer giant cells on the stent struts. The data were presented by Juan F. Granada, M.D., medical director of the Skirball Center for Cardiovascular Research and assistant professor at Columbia University Medical Center, New York, at the Transcatheter Cardiovascular Therapeutics symposium, TCT 2009, in San Francisco.
"We are very pleased with the pre-clinical outcomes of OrbusNeich's innovative Combo Stent," said Dr. Granada. "The biological effects observed with the Combo Stent could potentially translate into a clinical advantage by improving vascular healing while maintaining effective control of neointima proliferation, enhancing the safety profile of current drug eluting stents by harnessing the additive effect of EPC recruitment."
Endothelial coverage and functionality for the Combo Stent was demonstrated to be similar to the Genous(TM) Bio-engineered R stent(TM) at 14 days in the porcine model and revealed a 50 percent greater endothelialization rate than Cypher sirolimus-eluting stent as measured by visual microscopy and endothelial cell marker expression.
The Combo Stent combines the endothelial progenitor cell (EPC) capture technology found in OrbusNeich's Genous Bio-engineered R stent for accelerated healing with abluminal low dose sirolimus sustained drug elution for the control of neointimal proliferation.
Stephen M. Rowland, Ph.D., OrbusNeich's vice president of research and development, said, "Combo will enable us to expand on the benefits offered by our Genous technology. The results of this dual coating technology represent the culmination of our engineering efforts to achieve a partitioned effect on the body's response to stent injury. Our collaborative efforts with world class experts have paved the way for our soon to be initiated human clinical trial."