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

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 surgical intervention for hydrocephalus
• •5. Hypersensitivity or contraindication to heparin or radiographic contrast agents which cannot be adequately pre-medicated, desensitized or where no alternative is available
• •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 in cases 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) results outside 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 could conflict with study data collection or follow-up
• •16. Other medical illnesses that may cause the patient to be non-compliant with the protocol or confound data interpretation
• •17. Unwilling or unable to comply with follow-up requirements