A Medical Device Daily
Arbios Systems (Waltham, Massachusetts) said it has received conditional approval from the FDA for an Investigational Device Exemption to begin the pivotal clinical trial for SEPET, the company's extracorporeal artificial liver-assist device for blood purification of chronically ill patients suffering from acute liver failure.
Permission was granted to initiate the trial while the company responds to FDA's conditions and request for additional information, more specifically, end-points of the trial.
SEPET is a sterile, disposable cartridge containing microporous hollow fibers with proprietary permeability characteristics. When a patient's blood is passed through these fibers, blood plasma components of specific molecular weights are expressed through the micropores, thereby cleansing the blood of harmful impurities (hepatic failure toxins as well as various mediators of inflammation and inhibitors of liver regeneration).
Those substances would otherwise progressively accumulate in the patient's bloodstream during liver failure, causing hypotension, increasing risk of sepsis development and accelerating damage to the liver, lungs and other organs, including the brain and kidneys, and suppressing the function and regeneration of the liver.
SEPET is designed for use with standard blood dialysis systems available in hospital intensive-care units.
Arbios Systems makes devices and cell-based therapies to enhance the survival of patients who experience or are at risk for liver failure.