FDAnews Device Daily Bulletin

FIRST PATIENT ENROLLED IN TRIAL OF ARTIFICAL LIVER SUPPORT DEVICE

Dec. 7, 2005
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The Albert Einstein Medical Center in Philadelphia has enrolled the first patient in a clinical trial for the SEPET artificial liver support device, which was developed by Arbios Systems.

The Phase I safety trial of SEPET will evaluate the device's potential as a blood purifier to provide temporary liver support during acute-on-top-of-chronic liver failure and facilitate recovery from liver failure, support liver regeneration, and help keep liver failure patients alive until an organ becomes available for transplantation, according to the Einstein Medical Center.

The trial also will assess if the liver device can keep patients with liver failure healthier and in better condition until they undergo a transplant or their liver regenerates and recovers function.

SEPET is designed for use with a standard hemofiltration system but uses a cartridge containing hollow fibers with unique permeability characteristics. When a patient's blood is pumped through these fibers, the blood is cleansed of impurities and toxins that accumulate in liver failure. Arbios received conditional FDA approval in April for an investigational device exemption to begin a feasibility clinical trial for SEPET.

The first patient responded well to the device, said Santiago Munoz, chairman of the Division of Hepatology and director of the Einstein Center for Liver Disease. "We are extremely excited to be able to offer our critically ill liver patients an intervention which may serve as a bridge and improve their condition until they are transplanted," said Munoz, one of the lead investigators for the clinical trial.