FORT LAUDERDALE, Fla., Feb. 1 OrbusNeich announced today that data published in EuroIntervention (EuroIntervention, 2010; 5:698-702) demonstrated good safety and efficacy, low target vessel revascularization (TVR) and no late stent thrombosis at one year in patients with ST-elevation myocardial infarction (STEMI) who underwent primary percutaneous coronary intervention (PCI) and implantation of the company's Genous Bio-engineered R stent.
The prospective, observational study involved 321 patients with acute STEMI, without cardiogenic shock, who received 357 Genous stents. The rate of major adverse cardiac events (MACE) was 8.1 percent at 30 days, 10 percent at six months and 12.2 percent at one year. Only one patient developed acute stent thrombosis, and two others developed subacute stent thrombosis. There were no cases of late stent thrombosis. This was despite the fact that patients were treated with only one month of dual antiplatelet therapy. The data were published by Huay Cheem Tan, M.B.B.S., of National University Hospital in Singapore.
"The healing process at the culprit sites in patients with STEMI differs between bare metal stents and drug-eluting stents. There is pathologic evidence to suggest that the usage of DES results in delayed stent endothelialization and increases the likelihood of stent thrombosis," said Tan. "The positive results in this study, especially the low acute and subacute thrombosis rates, demonstrate that the pro-healing approach of the Genous stent makes the device safe for use in most patients with STEMI."
In the study, the TVR rate was 0.9 percent at 30 days, 2.8 percent at six months, and 4.4 percent at one year. Thirty percent of the patients in the study were diabetic, and 25 percent had bifurcation lesions.
Al Novak, OrbusNeich's chairman and chief executive officer, said, "These results support our previous observations that the safety profile of the Genous Bio-engineered R stent is very strong. Interventional cardiologists face several challenges when treating patients with acute coronary syndromes, including patients needing primary PCI for STEMI. We expect that further studies will continue to demonstrate the potential for Genous in treating these patients, as well as diabetic patients and those who cannot tolerate dual antiplatelet therapy."
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.