Safety and Performance Evaluation of the Nephronyx System for the Treatment of Patients With ADHF

Inclusion criteria

• Patient admitted to the hospital with a primary diagnosis of ADHF
• Patient has signs of volume overload as evidence by a score of ≥ 4 on the EVEREST score
• Patient with Left Ventricular Ejection Fraction LVEF >15%
• Patient has compromised response to diuretics
• NT-proBNP >450 pg/mL if aged <55 years, >900 pg/mL if aged between 55 and 75 years and >1800 pg/mL if aged >75 years

Exclusion criteria

• Patient with active DVT or history of DVT
• Patient has documented or evidence of Renal artery stenosis
• BMI>35 Kg/m^2
• Patient has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization
• Patient is in Cardiogenic shock
• Patient has blood dyscrasia, acute anemia, thrombocytopenia, bleeding diathesis, or coagulopathy
• Temperature > 38°C, or sepsis, or active systemic infection requiring IV anti-microbial treatment
• Patient has shown liver cirrhosis or has signs of liver damage