Evaluation of the Safety and Effectiveness of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus

Inclusion Criteria:

Each subject must meet the following criteria:

1. Patients ≥60 years old on the day of study informed consent

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

3. History or evidence of gait impairment with a duration ≥3 months

4. Clinical presentation consistent with NPH including two or more of the clinicaltriad (i.e., history of gait disturbance, progressive mental deterioration, andurinary urgency or incontinence), together with all of the following:

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. Patient is willing and able to attend all scheduled visits and comply with studyprocedures.

10. Confirmation of anatomy suitable for the eShunt procedure, as determined byevaluation of pre-procedure imaging (CT and MRI) and approved by an independentanatomical screening committee.

Exclusion Criteria:

Each subject may not:

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

2. Be diagnosed with obstructive hydrocephalus

3. Have an active systemic infection or infection detected in CSF

4. Have had prior or existing shunts, endoscopic third ventriculostomy, or any previoussurgical intervention for hydrocephalus

5. Demonstrate hypersensitivity or contraindication to heparin or radiographic contrastagents against which the subject cannot be adequately pre-medicated, desensitized orwhere no alternative is available

6. Have occlusion or stenosis of the internal jugular vein which would prohibit accessto the IPS

7. Present with venous distension in the neck on physical exam

8. Have medical conditions associated with prolonged elevation of jugular venouspressure, including jugular vein stenosis or stricture, right sided heart failure,cirrhosis of the liver, arteriovenous fistulas in the arm for dialysis purposes, oran arterial venous fistula or malformation in the neck or brain

9. Have history of bleeding diatheses, coagulopathy or refuse to consent for bloodtransfusion in cases of emergency

10. Have had an ischemic stroke or transient ischemic attack within 180 days of eShuntprocedure

11. Have documented evidence of a deep vein thrombosis superior to the popliteal vein

12. Have intrinsic blood clotting disorder

13. Have medical conditions requiring anticoagulation which is unable to be managed toallow for surgical procedure

14. Have presence of a posterior fossa tumor or mass

15. Have a life expectancy <1 year

16. Be currently participating in another interventional (drug, device, etc.) researchproject that may confound the results of this study.

17. Have established diagnosis of neurodegenerative diseases such as Parkinson'sdisease, Alzheimer's disease, or Lewy body dementia

18. Be diagnosed with schizophrenia or any psychiatric diagnosis (including depression)that may complicate outcome evaluation

19. Need an intracranial neurosurgical procedure within 180 days of study indexprocedure

20. Be unwilling or unable to comply with follow-up requirements

21. Have mRS of 0, 5, or 6