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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 ...

Sat, 09/25/2010 - 9:32am
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

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