The objective of this interventional study is to evaluate the safety and functional performance of the Nephronyx System in patients with ADHF, presenting clinical signs of volume overload and compromised response to diuretics.
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
Patient with active DVT or history of DVT
Patient has documented or evidence of Renal artery stenosis
BMI>35 Kg/m²
Patient has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization
Single group
Nephronyx system (Perfuser)
DeviceTemporary deployment of the Nephronyx system (Perfuser)
Serious Adverse Events
Device and/or investigational procedure related SAEs
Performance/ Procedural success
Device preforms as planned with no associated device malfunction
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