Randomized TRIAS HR Pilot Study Compares Genous, Boston Scientific's
Taxus(R) Other Presentations Focus on Real-World Use of Genous, Stent's Performance
in Patients with AMI, Those Who Could Not Tolerate Dual-Antiplatelet
BARCELONA, Spain, May 15 /PRNewswire/ -- OrbusNeich today announced that multiple clinical data presentations in a symposium at EuroPCR 2008 support the use of the company's Genous Bio-engineered R stent, the world's first pro-healing stent, as a safe alternative to drug-eluting stents.
12-Month TRIAS HR Pilot Study Data
Presented by Robbert de Winter, M.D., Ph.D., of the Academic Medical Center in Amsterdam, data from the TRIAS HR (high risk) Pilot study show similar target vessel failure (TVF) rates at 12-month follow-up for OrbusNeich's Genous Bio-engineered R stent and Boston Scientific's Taxus stent in high risk of restenosis patients.
In the patients treated with Taxus, there were four out-of-hospital thrombotic events, while there were no reported events in the Genous group. TRIAS HR Pilot is a randomized, 193-patient, single-center, prospective, single-blind study involving patients with a high risk of restenosis. High risk of restenosis is defined as patients who have diabetes mellitus and/or small vessels (less than 2.8 mm) and/or long lesions (greater than 23 mm) and/or chronic total occlusions.
"Interventional cardiologists need better stent technologies," said de Winter, principal investigator of the TRIAS HR Pilot study. "A pro-healing approach with the Genous stent is a viable one. We look forward to obtaining further data on the stent's performance in our large, multi-center TRIAS trials that compare Genous to both drug-eluting and bare metal stents."
e-HEALING Interim Patient Subset Data
In addition, de Winter presented interim follow-up data from patient
subsets of e-HEALING, a monitored, m
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