Safety and Performance of the Automated Fluid Shunt in Patients With Ascites and Diuretic Resistance

Inclusion Criteria: * Patients ≥ 18 years of age * Recurrence of ascites defined as clinical reappearance of ascites within 4 weeks of initial paracentesis. * Cirrhosis of any etiology * Failure to respond to a maximum of 160 mg/d of furosemide and 400 mg/d of spironolactone (or equivalent doses of loop-acting and distal-acting diuretics), or intolerance to high dose diuretics because of hyponatremia, hyperkalemia, or other side-effects * Dietary sodium restriction \<88mEq/d. * Serum creatinine levels of ≤ 2.0 mg/dL for at least 7 days before study entry. * Total bilirubin levels of less than 3 mg/dL. * Expected survival of greater than 6 months * Written informed consent * Ability to comply with study procedures and ability to operate the device. * Women of childbearing age should use adequate contraceptives Exclusion Criteria: * Presence of recurring systemic or local infection, such as peritonitis, urinary tract infection, or abdominal skin infection. * Presence of peritoneal carcinomatosis * Advanced hepatocellular carcinoma, demonstrated by: 1. One tumor that is \>5 cm diameter 2. 3 or more nodules of \>3 cm diameter 3. Portal thrombosis * Other evidence of a malignant Etiology for Ascites * Evidence of extensive ascites loculation * Gastrointestinal hemorrhage due to portal hypertension in the 2 weeks prior to the inclusion in the study. * Hepatic encephalopathy in the two weeks prior to implant * Presence of a TIPS or surgical portosystemic shunt * Presence of Budd-Chiari syndrome * Previous liver transplant * Obstructive uropathy * Coagulopathy that could not be corrected to a prothrombin time INR \<1.8, * Thrombocytopenia that could not be corrected to a platelet count greater than 60,000/mm3 * Any other clinically significant disease that could be adversely affected by study participation judged by the Investigator * Any condition requiring emergency treatment * Pregnancy * Patients being in another clinical study that did not reach primary endpoint yet