Clinical Trials
U.S. FDA guidance allows for shipment of liver assist system cartridges to China
Published in Medical Letter on the CDC and FDA, February 5th, 2006
Allowance to ship the cartridges was the final step required for pivotal clinical trials of the ELAD to begin in China in early 2006. VTI plans to confirm ELAD's safety and efficacy in these trials, which will serve as the basis for China approval and launch.
Liver disease is endemic in China and causes more than 400,000 deaths annually. If approved, the ELAD system will be the first ever human cell-based support...
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