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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 …

September 25, 2010 By Bio-Medicine.Org

WASHINGTON, Sept. 25 /PRNewswire/ — OrbusNeich today announced
that clinical trial results highlighting the company’s Genous
Bio-engineered R stent and its endothelial progenitor cell (EPC)
capture technology across challenging patient subsets were
presented during a symposium titled “EPC Capture Technology: from
Genous to Combo” at Transcatheter Cardiovascular Therapeutics (TCT)
2010 in Washington.

Genous Bio-engineered R stent is safe and effective in
diabetic patients,
elderly patients and in patients who
stopped dual antiplatelet therapy (DAPT) at 30 days and at six
months
due to increased risk for bleeding or DAPT
cessation
.

Professor Robbert de Winter, M.D., Ph.D., of the Academic
Medical Center in Amsterdam presented a subset analysis from the
global e-HEALING registry. The findings included:

  • Twelve-month follow-up data that compared results from 339
    elderly patients over the age of 80 to 4,584 patients under the age
    of 80 showed that the elderly patients had significantly more risk
    factors such as hypertension and acute coronary syndrome (ACS) and
    presented with more complex lesions. Compared to the younger
    cohort, elderly patients had higher rates of target vessel failure
    (TVF) driven mainly by cardiac death. Significantly, the rate of
    late stent thrombosis at 12 months in elderly patients (0.3
    percent) was shown to be low and similar to that of the younger
    patient group (0.2 percent).
  • Twelve-month outcomes were shown to be similar between patients
    who stopped DAPT at 30 days and those who continued on DAPT; the
    TVF rates of the two subgroups were 6.3 percent and 6.5 percent,
    respectively.  The subset analysis also showed that 12-month
    outcomes were similar between patients who stopped DAPT at six
    months and those who continued; the TVF rates of the two subgroups
    were 2.8 percent and 2.4 percent, respectiv

    ‘/>”/>

SOURCE

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