The Safety and Feasibility of the eLym™ System

Inclusion Criteria:

1. Age ≥ 18 years

2. Subject is admitted to the hospital with a primary diagnosis of Acute DecompensatedHeart Failure (ADHF)

3. Subjects receiving intravenous (IV) diuretic for decompensated heart failure anddemonstrating fluid overload. This includes peripheral edema ≥2+ (on a 0 to 4+scale) and a minimum of 1 of the following:

• Jugular venous distension ≥10 cm H20;

• Pulmonary edema as determined by auscultation or imaging;

• Hepatojugular reflux;

• Paroxysmal nocturnal dyspnea or ≥ two-pillow orthopnea;

• Dyspnea at rest with respiration rate ≥20 per minute.

4. Total DAILY diuretic dose prior to admission of ≥80mg Lasix or equivalent

5. Renal function parameters as measured by estimated glomerular filtration rate (eGFR) ≥20 ml/min/1.73m2

6. Subject must meet on one of the following criteria:

• Subject has had a heart failure hospitalization or worsening of heart failureevent requiring IV diuretic therapy (in hospital, emergency room, urgent care,or HF clinic) within the previous 6 months;

• Renal function as measured by eGFR ≥20 and ≤45 ml/min/1.73m2;

• At initial HF admission, <600 ml of urine output within 6 hours of initial IVbolus or urine sodium of <50 mmol/L at 1-2 hours after initial IV diureticdose.

7. Elevated N-Terminal (NT) Pro B-type Natriuretic Peptide (BNP) or BNP:

• NT Pro BNP >1000 pg/ml (>1500 for subjects with atrial fibrillation);

• BNP >250 pg/ml (>375 for subjects with atrial fibrillation).

8. Albumin >2.5 g/dL

9. Subject must be able to have device placement procedure within 96 hours ofpresentation to the hospital and still be demonstrating fluid overload at the timeof device placement

10. Subject willing and able to complete study assessments and agrees to comply with allfollow-up evaluations

11. Subject has provided written informed consent

Exclusion Criteria:

1. Ultrasound Screening Assessment Exclusion:

• Subjects have anatomical abnormalities that would affect the insertion anddeployment of the eLym System

• Subject has vein diameters at anticipated sites of deployment balloons that arenot within the following specifications:

• Proximal restriction balloon site must have a venous diameter of 8 - 18millimeters (mm)

• Distal balloon site must have a diameter of 12 - 20 mm

2. Subjects requiring intravenous vasoactive therapies (e.g., vasodilators,inodilators, inotropes), mechanical ventilation, MCS, or ultrafiltration

3. Subject has experienced a thromboembolic event [e.g., pulmonary embolism (PE), deepvein thrombosis (DVT), transient ischemic attack (TIA), or cerebrovascular events (CVA)] within the previous 6 months

4. Subject has contraindications to systemic anticoagulation

5. Subject currently on Dabigatran

6. Subject with International Normalized Ratio (INR) >2.2 not due to anticoagulationtherapy, hypercoagulable state including heparin-induced thrombocytopenia, or onnovel anticoagulants (NOACs) that cannot be held for a minimum of 24 hours prior toeLym System placement Note: If subject's INR is >2.2 at the screening and baselineassessment, it may be repeated to assess eligibility up to the time of theprocedure.

7. Previous intracranial bleed unless there is documentation that the patient cansafely use anticoagulation for 3 days

8. Gastrointestinal (GI) bleeding within 6 months requiring hospitalization and/ortransfusion.

9. Recent major surgery within 30 days if the surgical would is judged to be associatedwith increased risk of bleeding.

10. Platelet count <75 10^3/μL

11. Inability to tolerate anticoagulation therapy for up to 3 days

12. Subject with systolic blood pressure <85 millimeters of mercury (mmHg) at time ofenrollment

13. Subject has severe liver disease, liver fibrosis, or hempatorenal syndrome

14. Subject has evidence of active blood stream infection or pneumonia

15. Sustained malignant arrhythmias [e.g., ventricular tachycardia/fibrillation) in thelast 90 days]

16. Subject with acute coronary syndrome (ACS) in the last 3 months

17. Subject with severe concomitant disease expected to prolong hospitalization orexpected to cause death in ≤ 90 days

18. Subject with a rhythm management device implanted within the last 45 days (i.e.,cardioverter/defibrillator, pacemaker, cardiac resynchronization device)

19. Subject is pregnant or lactating. Women of childbearing age who are notpost-menopausal or not surgically sterile will need to demonstrate a negative urineor serum test.

20. Physician discretion