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OrbusNeich's e-HEALING clinical study is a monitored multi-center,worldwide (outside the United States) prospective registry of patients treatedwith the Genous Bio-engineered R stent. The study protocol recommends thatpatients receive one month of clopidogrel treatment after the procedure.Clinical follow-up takes place at 30 days, six months and 12 months. Theprimary endpoint of the registry is target vessel failure at 12 months.
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"We reached this significant enrollment milestone earlier than weexpected," said Sigmund Silber, M.D., F.A.C.C., F.E.S.C., professor ofmedicine, a co-principal investigator of the study. "This reflects anincrease in demand and use for Genous by physicians concerned with drug-eluting stents."
Robbert de Winter, M.D., Ph.D., F.E.S.C., a co-principal investigator ofthe study and director of the catheterization laboratory at the AcademicMedical Center in Amsterdam, added: "We look forward to our continuedreporting of the patient follow-up data. Our next presentation is expected tobe at the American College of Cardiology's annual scientific session earlynext year."
Unlike drug-eluting stents, Genous is coated with an antibody thatcaptures a patient's endothelial progenitor cells (EPCs) to accelerate thenatural healing process. EPCs circulate in the bloodstream and are involvedin the repair of blood vessels. When attracted to the surface of Genous, EPCsrapidly form an endothelial layer over the stent that provides protectionagainst thrombus and minimizes restenosis.
"Completing enrollment in this large registry is an important milestone inour clinical development," said Samuel Rasmussen, OrbusNeich's president andCEO.
OrbusNeich designs, develops, manufactures and markets innovative medicaldevices for the treatment of vascular diseases. In addition to GenousOrbusNeich's products are stents, balloons and guiding catheters marketedunder the names of Blazer(TM), R stent(TM), Sapphire(TM), Avita(TM), AvitaHP(TM), SafeCut(TM), Lumina(TM) and Saffron.
A global company, OrbusNeich is headquartered in Hong Kong and hasoperations in Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; and Shenzhen,China. OrbusNeich, which has provided cardiology devices to physiciansthrough its predecessor companies since 1979, today supplies products in morethan 60 countries. For more information, visit www.OrbusNeich.com.
SOURCE OrbusNeich
