BARCELONA, Spain, May 23, 2007 /PRNewswire/ -- The efficacy of OrbusNeich's Genous(TM) Bio-engineered R stent compares favorably to that of drug-eluting stents, while the risk of late thrombosis is minimized with the Genous stent, according to an interim analysis of post-marketing data presented today by Robbert de Winter, M.D., Ph.D., at EuroPCR 2007 in Barcelona, Spain.
Collected from more than 120 sites in 29 countries, follow-up data for patients who received at least one Genous Bio-engineered R stent show:
-- For 2,175 patients at 30 days, the target lesion revascularization (TLR) rate was 0.05%, the major adverse cardiac events (MACE) rate was 1.61%, and the sub-acute thrombosis (SAT) rate was 0.37% -- For 1,039 patients at six months, the TLR rate was 2.89%, the MACE rate was 5.87%, and the thrombosis rate was 0.88%
"The real-world data speak to the promise of OrbusNeich's innovative pro- healing approach with Genous, especially when we compare the findings to those of the drug-eluting stent registries," said de Winter, a co-principal investigator of the study and director of the catheterization laboratory at the Academic Medical Center in Amsterdam. "The importance of this interim data is that Genous appears to be as effective as drug-eluting stents with only the need for minimal dual-antiplatelet therapy, which is safer for patients and less expensive."
OrbusNeich's e-HEALING is a multi-center, worldwide prospective
registry of patients treated with the Genous Bio-engineered R stent
in accordance with the instructions for use. The protocol
recommends that patients receive two weeks of statin treatment
prior to the procedure and 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 reg