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OrbusNeich's Genous(TM) Bio-engineered R stent(TM) Demonstrates Good Safety and Clinical Outcomes in Patients with Primary PCI for STEMI
Date:2/1/2010

FORT LAUDERDALE, Fla., Feb. 1 /PRNewswire/ -- 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 2
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1. Final 12 Month Clinical Data from 5,000 Patients in Worldwide e-HEALING Clinical Study Show Good Safety and Efficacy with Real World Use of OrbusNeichs Genous(TM) Bio-engineered R stent(TM)
2. OrbusNeichs Genous(TM) Bio-Engineered R Stent(TM) is Safe in a Broad Population of Patients with Primary PCI for STEMI
3. OrbusNeichs Genous(TM) Bio-engineered R stent(TM) is Feasible in Patients Requiring Undeferrable Non-Cardiac Surgery, International Journal of Cardiology Publication Reports
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