CLINICAL AND LABORATORY EVALUATION OF THE SAFETY OF A BIOARTIFICIAL LIVER ASSIST DEVICE FOR POTENTIAL TRANSMISSION OF PORCINE ENDOGENOUS RETROVIRUS

Abstract

Although longer patient follow-up is required and mandated to unequivocally establish the biosafety of this device and related bioartificial organ systems, these analyses support the conclusion that when used under standard operational conditions, the BLSS is safe.