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OrbusNeich Announces First Patient Enrolled in REMEDEE, a Randomized Clinical Trial of the Combo Bio-engineered Sirolimus Eluting Stent
Date:12/1/2009

ent," said Dr. Thambar. "This innovative technology potentially represents the next generation of coronary stents."

The Combo Stent is designed to combine the pro-healing technology used in OrbusNeich's Genous(TM) Bio-engineered R stent(TM) for rapid endothelial coverage with an abluminal sirolimus drug elution for the control of neointimal proliferation. The low dose sirolimus elution is accomplished through the use of the SynBiosys(TM) biodegradable polymer matrix from SurModics, Inc. ( SRDX).

"The pre-clinical work has shown the effectiveness of combining the endothelial progenitor cell capture technology to promote endothelialization coupled with the low dose, abluminal sirolimus elution to regulate hyperplasia," said Ian T. Meredith, M.B.B.S., Ph.D., Professor of Cardiology, Director of MonashHeart and Executive Director of the Monash Cardiovascular Research Centre, Melbourne, Australia, one of the trial's principal investigators. The other principal investigators are Stephan Windecker, M.D., director of invasive cardiology at the University Hospital Bern in Switzerland, and Alexandre Abizaid, M.D., Ph.D., director of the catheterization laboratory at the Institute Dante Pazzanese of Cardiology in Sao Paulo, Brazil. "The Combo Stent could be the best of both world's approach for patients at the highest risk of restenosis," Meredith added.

"The Combo Stent has demonstrated significantly lower neointimal hyperplasia, improved endothelial coverage relative to commercially available drug-eluting stents and lower presence of inflammation and foreign body reaction in multiple pre-clinical studies," said Renu Virmani, M.D., president and medical director of CVPath Institute, Inc. "Furthermore, I have long believed that the next generation of stents can benefit from biodegradable polymers. The data I've seen on the SynBiosys biodegradable polymer suggest it is very biocompatible with low inflammatory scores that could also resul
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SOURCE OrbusNeich
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