A unique hollow fiber membrane oxygenator (IVOX) has been developed, which is inserted into the vena caval blood stream to transfer O2/CO2 to/from circulating blood in an intact subject without involving the natural lungs. Extensive laboratory testing has demonstrated that the device can transfer significant quantities of O2 and CO2 for up to 3 weeks without significant harmful sequelae or complications. Clinical trials are in progress under FDA supervision, in which IVOX has been utilized to date in 56 patients with ARDS. Preliminary findings indicate that risks and hazards from IVOX are nil, and evidence of benefit to the patient has been demonstrated in 86% of the patients. At this time, clinical utilization of IVOX is in the experimental, data collecting mode to determine its proper role or niche as a method for temporary augmentation of blood gas transfer in patients with advanced acute respiratory failure.