Study Says Genous Bio-Engineered R Stent is Feasible in Patients Requiring Undeferrable Noncardiac Surgery
September 14, 2009 – OrbusNeich's Genous Bio-engineered R stent is feasible and safe in patients who need coronary revascularization before undeferrable noncardiac surgery and have to discontinue dual anti-platelet therapy, according to a paper published online in the International Journal of Cardiology.
The paper, “A new approach to percutaneous coronary revascularization in patients requiring undeferrable noncardiac surgery," is based on a study of 30 patients who needed coronary revascularization followed by an endovascular or surgical procedure. All of the patients were treated with the Genous stent, and there were no cardiac events reported at 30-days follow-up after surgery. The dual anti-platelet therapy was stopped before surgery, achieving an average anti-platelet therapy time of 12.2 +/- 3.9 days. The surgery was performed after anti-platelet therapy interruption at an average interval from revascularization of 17.2 +/- 3.9 days.
"The literature on an optimal strategy for high cardiovascular risk patients requiring undeferrable surgery remains limited," said Federico Piscione, M.D., of Federico II University in Naples, Italy, lead author of the publication. "This study adds to the body of knowledge that this Genous healing stent could allow surgical procedures to be performed soon after stent deployment and DAT (dual anti-platelet therapy) discontinuation."
Genous is OrbusNeich's patented endothelial progenitor cell (EPC) capture technology that promotes the accelerated natural healing of the vessel wall after the placement 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 is commercially available in more than 60 countries and was first used in 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, the company said. There is a growing body of evidence from multiple clinical studies that the Genous stent is effective for patients who are nonresponsive to or cannot tolerate long-term dual anti-platelet therapy.
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