Early Feasibility Study of the NORM™ System in Heart Failure Patients (FUTURE-HFII)

Main Inclusion Criteria

• Adults 18 years of age or older.

• Patients meeting diagnostic criteria for heart failure diagnosis for greater than 90days and are on optimally tolerated medical therapy for at least 30 days, asrecommended according to current AHA/ACC/HFSA guidelines with any intolerance orcontraindications documented, regardless of ejection fraction, as evidenced bymeeting either 2a, 2b, OR 2c criterion below:

1. NYHA functional class III: with documented HF decompensation within theprevious 12 months resulting in a primary HF hospitalization, HF treatment in ahospital day-care setting or unscheduled visit to a healthcare provider foradministration of an intravenous diuretic to treat HF and NT-proBNP ≥600 pg/mL (or BNP ≥200 pg/mL). For patients presenting with atrial fibrillation NT-proBNP ≥900 pg/mL (or BNP ≥300 pg/mL).OR

2. NYHA functional class III: NT-proBNP ≥1000 pg/mL (or BNP ≥300pg/mL). Forpatients presenting with atrial fibrillation NT-proBNP≥1,600 pg/mL (or BNP ≥500pg/mL).OR

3. NYHA functional class II: with documented HF decompensation within the previous 12 months resulting in a primary HFhospitalization, HF treatment in a hospitalday-care setting or unscheduled visit to a healthcare provider foradministration of an intravenous diuretic to treat HF AND NT-proBNP ≥1000 pg/mL (or BNP ≥300 pg/mL). For those patients presenting with atrial fibrillationNT-proBNP ≥1,600 pg/mL (or BNP ≥500 pg/mL).

• Patients must also be on a daily dose of loop diuretic of 40mg or more furosemide,or equivalent, for the 2 weeks prior to screening.

• IVC diameter within the landing zone of between 14mm and 28mm.

• Minimum IVC landing zone length of 60mm.

• Patient has sufficient Cellular and/ or Wi-Fi Internet coverage at home.

• Provide informed consent for participation in the clinical investigation and bewilling and able to comply with the required daily system readings, care planinstructions, and clinical follow-up visits according to the specified schedule.

Main Exclusion Criteria:

• Significant comorbidity that, in the investigator's opinion, would results in thepatient being unable to safely undergo the procedure or participate in the clinicalinvestigation.

• Patients with an estimated Glomerular Filtration Rate (eGFR) < 25 ml/min/1.73m2

• Patients with an in vivo IVC filter, abnormal IVC or femoral venous anatomy or knowncongenital malformation or absence of IVC or occlusive or free-floating thrombus inthe IVC.

• Patients who have severe right sided valvular disease or a right sided mechanicalvalve.

• Patients with a cardiac resynchronization therapy device implanted ≤ 3 months toprior to screening.

• Patients who have undergone invasive cardiac surgery in the 3 months prior toscreening.

• Patients who have undergone percutaneous valve / structural heart intervention in inthe 3 months prior to screening.

• Patients who have received heart transplant or a ventricular assist device orplanned for advanced therapies within the next year.

• Patients with conditions associated with occlusion of the IVC, iliac or commonfemoral veins.