FDAnews Device Daily Bulletin

FDA ALLOWS EXPANSION OF CLINICAL SITES IN LIVER DEVICE TRIAL

March 23, 2006
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Arbios Systems, a biomedical device and cell therapy company, has announced that the FDA has allowed the expansion of the number of clinical sites and increased the allowable number of patients in the company's IDE feasibility trial for the SEPET liver assist device.

Under the revised protocol, Arbios can include up to four clinical trial sites and to up to 20 liver failure patients with encephalopathy. The trial was previously limited to two sites and 15 patients. Encephalopathy is a life-threatening condition involving brain dysfunction, which is caused by toxins that accumulate in the bloodstream during liver failure.

The company also announced that the University of California at San Diego (UCSD) Medical Center would serve as an additional clinical site in the trial. UCSD joins Cedars-Sinai Medical Center in Los Angeles and Albert Einstein Medical Center in Philadelphia as authorized clinical sites for the ongoing trial.

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