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Multiple Clinical Data Presentations at EuroPCR 2008 Support Use of OrbusNeich's Genous(TM) Bio-engineered R stent(TM) as Safe Alternative to Drug-Eluting Stents
Date:5/15/2008

ulti-center, worldwide (outside the United States) prospective registry with 5,000 enrolled patients. The data based on the real-world use of the Genous Bio-engineered R stent show:
-- Good clinical outcomes at six and 12 months

-- A low target lesion revascularization (TLR) rate of 4.7% at 12 months

in patients with diabetes

-- A low incidence of stent thrombosis

The protocol for OrbusNeich's e-HEALING registry recommends that patients receive one month of clopidogrel treatment after the procedure. Clinical follow-up takes place at 30 days, six months and 12 months. The primary outcome of the registry is TVF at 12 months.

"Genous appears to have the same efficacy as drug-eluting stents but a better safety profile with only minimal dual-antiplatelet therapy requirements," de Winter said.

Acute Myocardial Infarction (AMI) Patients

Huay-Cheem Tan, M.D., of National University Hospital in Singapore discussed published follow-up data on a study involving an initial 120 patients with AMI. The six-month data show a very low MACE rate of 5.8% with an early stent thrombosis rate of 1.7% and no reported thrombotic events from one to six months.

As part of an extended registry study, 321 patients with AMI were followed for one year. Even with the larger patient group, the MACE rate was 13.1% at one year with no mortality beyond the first month. The early stent thrombosis rate was 0.9% with no further thrombotic events beyond one month. The patients received dual-antiplatelet therapy for only 30 days.

In a comparison of a subset of diabetic patients with AMI, the Genous group had a six-month MACE rate of 8.9%, while a historical group of patients with bare metal stents (BMS) had a MACE rate of 15.4%. No thrombotic events were reported in the Genous group, and one event was reported in the BMS group.

"Based on a comparison of published data, our findings demonstrate that the Genous stent is feasibl
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SOURCE OrbusNeich
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