US Pilot Study of the CereVasc® EShunt® System in Normal Pressure Hydrocephalus

Inclusion Criteria:

1. Patients 65-85 years old for whom traditional CSF shunt placement is indicated basedupon a diagnostic normal pressure hydrocephalus (NPH) evaluation

2. Patient or legally authorized representative is able and willing to provide writteninformed consent

3. History or evidence of gait impairment duration ≥6 months

4. Clinical presentation consistent with NPH including 2 or more of the clinical triad (i.e., history of gait disturbance, progressive mental deterioration, and urinaryurgency or incontinence), together with:

5. Brain MRI signs of ventricular enlargement disproportionate to cerebral atrophy (Evans' Index >0.3) and the absence of severe hippocampal atrophy

6. Pre-procedure spinal tap test or lumbar drain with subsequent gait disturbanceimprovement (Timed Up and Go Test) of at least 20%

7. CSF opening pressure ≥8 cmH2O

8. Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA)test score ≥12

9. Pre-procedure MRI confirmation of anatomy suitable for eShunt Procedure, asdescribed in Section 1.8.3.4.2 and confirmed by subject screening committee (SSC)

10. Pre-procedure CT confirmation of anatomy suitable for eShunt Procedure, as describedin Section 1.8.3.4.2 and confirmed by SSC

Exclusion Criteria:

1. Unable to walk 10 meters (33 feet) with or without an assistive device

2. Signs or symptoms of obstructive hydrocephalus

3. Active systemic infection or infection detected in CSF

4. Prior or existing shunts, endoscopic third ventriculostomy, or any previous surgicalintervention for hydrocephalus

5. Hypersensitivity or contraindication to heparin or radiographic contrast agentswhich cannot be adequately pre-medicated, desensitized or where no alternative isavailable

6. Occlusion or stenosis of the internal jugular vein

7. Venous distension in the neck on physical exam

8. Atrial septal defect or patent foramen ovale identified on cardiac echocardiogram

9. History of bleeding diatheses, coagulopathy or will refuse blood transfusion incases of emergency

10. Stroke or transient ischemic attack within 180 days of eShunt Procedure

11. Presence of a deep vein thrombosis superior to the popliteal vein

12. International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) resultsoutside of normal range (INR 0.8-1.4; PTT 25-35 seconds)

13. Presence of a posterior fossa tumor or mass

14. Life expectancy < 1 year

15. Currently participating in another investigational drug or device trial that couldconflict with study data collection or follow-up

16. Other medical illnesses that may cause the patient to be non-compliant with theprotocol or confound data interpretation

17. Unwilling or unable to comply with follow-up requirements