Arbios Systems Inc. has received approval from the FDA for an investigational device exemption to begin the pivotal clinical trial for its liver-assist device, SEPET, for purifying blood in acutely ill patients with chronic liver disease. When a patient’s blood is passed through the device containing microporous, hollow fibers, blood plasma components are cleansed of harmful impurities. These impurities would otherwise accumulate in the patient’s bloodstream during liver failure, causing hypotension, increasing the risk of sepsis development and accelerating damage to the liver, lungs and other organs.