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Data Show OrbusNeich's Genous™ Bio-engineered R stent™ is Safe and Effective in Combination with Drug-Eluting Balloon
Date:6/21/2010

BEIJING, June 21 /PRNewswire/ -- OrbusNeich today announced that six-month clinical follow-up data show the safety and efficacy of the combination of pre-dilatation with a paclitaxel drug-eluting balloon (Sequent Please®, B.Braun) followed by implantation of the company's Genous Bio-engineered R stent for the percutaneous treatment of coronary artery stenosis.

In the investigator-initiated, single center, all-comers POTENT (Paclitaxel-eluting ballOon and bio-engineered progeniTor cEll-attracting stainless steel steNT in percutaneous treatment of coronary artery stenosis) registry, 32 percent of patients were diabetic, 86 percent were male, 58 percent had a previous myocardial infarction and the mean age of the study population was 56 years. Of the lesions treated, 46 percent were type B2/C lesions.  The patients received a pre-loading of dual antiplatelet therapy (DAPT) at least six hours prior to the percutaneous coronary intervention, and the DAPT was continued for three months. There were no in-hospital or 30 day major adverse cardiac events (MACE) reported.  There was one case of late stent thrombosis.

In the six-month clinical follow-up of the 50 patients in the study, the MACE rate was six percent, and the clinical driven target lesion revascularization (TLR) rate was four percent. In an optional nine-month angiographic follow-up of 35 patients, no patients exhibited binary restenosis. Alan Yean Yip Fong, M.D., of the Sarawak General Hospital in Malaysia presented the data during the World Congress of Cardiology Scientific Sessions 2010 in Beijing.

"We are very encouraged by the low MACE and binary restenosis rates, which are comparable to other stenting strategies and demo
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SOURCE OrbusNeich
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1. Enrollment Reaches 110 Patients in Investigator Initiated, Randomized Trial of OrbusNeichs Genous(TM) Bio-Engineered R Stent(TM)
2. OrbusNeichs Genous(TM) Bio-Engineered R Stent(TM) is Subject of Sessions on Innovation at TCT 2007
3. Preliminary Results of Randomized Pilot Study Show Comparable Efficacy for OrbusNeichs Genous(TM) Bio-engineered R Stent(TM) and Boston Scientifics Taxus(R) Stent in Patients at High Risk of Restenosis
4. OrbusNeichs Genous(TM) Bio-engineered R Stent(TM) has Lower MACE Rate than TAXUS(R) and CYPHER(R) Stents in Clinical Trial
5. Clinical Impact of OrbusNeichs Genous(TM) Bio-engineered R stent(TM) is Subject of Symposium at 16th Annual Scientific Congress of Hong Kong College of Cardiology
6. Data from Randomized Pilot Study, Real-World Use of OrbusNeichs Genous(TM) Bio-engineered R stent(TM) to be Presented in Symposium at EuroPCR 2008
7. Multiple Clinical Data Presentations at EuroPCR 2008 Support Use of OrbusNeichs Genous(TM) Bio-engineered R stent(TM) as Safe Alternative to Drug-Eluting Stents
8. Data Presented at Annual Meeting of Japanese Society of Interventional Cardiology Demonstrate OrbusNeichs Genous(TM) Bio-engineered R Stent(TM) Has Better Outcomes When Compared to Drug-Eluting Stents
9. Data From Multiple Clinical Trials of OrbusNeichs Genous(TM) Bio-engineered R stent(TM) to be Presented at TCT 2008
10. Interim Analysis of 12-Month Data from e-HEALING Registry Shows Good Safety and Efficacy in Real-World Use of OrbusNeichs Genous(TM) Bio-engineered R stent(TM)
11. Long Term Data Presented at EuroPCR 2009 from Randomized Study Attest to Durability of Results of OrbusNeichs Genous(TM) Bio-engineered R stent(TM) Compared to Drug-Eluting Stents
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