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Data from Multiple Clinical Trials of OrbusNeich's Genous™ Bio-engineered R Stent™ Demonstrate Safety and Effectiveness Across Challenging Patient Subsets as Presented at TCT 2010
Date:9/25/2010

ely. Both patient subgroups showed a low definite or probable stent thrombosis similar to the corresponding control groups.

Professor de Winter, a co-principal investigator of the study, said, "The e-HEALING data demonstrate the safety and excellent clinical outcome profile of the Genous Bio-engineered R stent in elderly patients and patients on only one month of DAPT."

e-HEALING is a multi-center, worldwide (outside of the United States) prospective clinical registry conducted in 31 countries at 144 clinical centers.

Genous Bio-engineered R stent demonstrates effectiveness and safety and does not increase risk of in-stent thrombosis in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS).

Professor Wojciech Wojakowski, M.D., of the Third Division of Cardiology, Katowice, Poland, presented 12-month follow-up results from the JACK-EPC clinical trial, an investigator-initiated, randomized trial that compared the Genous Bio-engineered R stent with bare metal stents (BMS) in 60 patients with NSTE-ACS.  The results showed:

  • The major adverse cardiac event (MACE) rate in Genous Bio-engineered R stent treated patients was 13.3 percent compared to 23.3 percent in BMS patients, and no in-stent thrombosis was apparent in either cohort at 12-month follow-up.

  • At six months, the in-stent late loss in the Genous Bio-engineered R stent treated patient group was 0.45 mm compared to 0.86 mm in the BMS treated group, and the binary restenosis rate was 13 percent versus 26.6 percent, respectively.

The primary endpoints of the study were in-stent loss and binary restenosis. MACE was defined as cardiovascular death, myocardial infarction and any hospitalization for ASC.

"The 12-month results show that the Genous Bio-engineered R stent i
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