Pilot Study to Evaluate the CereVasc® EShunt® System in the Treatment of Communicating Hydrocephalus

Exclusion Criteria

• •Presence of gross blood in CSF
• •Signs or symptoms of obstructive hydrocephalus
• •Active systemic infection or infection detected in CSF
• •Prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus
• •Hypersensitivity or contraindication to heparin or radiographic contrast agents which cannot be adequately pre-medicated, desensitized or where no alternative is available
• •Occlusion or stenosis of the internal jugular vein
• •Venous distension in the neck on physical exam
• •Medical conditions associated with prolonged elevation of jugular venous pressure, including jugular vein stenosis or stricture, right sided heart failure, cirrhosis of the liver, arterial venous fistulas in the arm for dialysis purposes, or an arterial venous fistula or malformation in the neck or brain
• •Atrial septal defect or patent foramen ovale identified on cardiac echocardiogram
• •History of bleeding diatheses, coagulopathy or will refuse blood transfusion in cases of emergency
• •Stroke or transient ischemic attack within 180 days of eShunt Procedure
• •Presence of a deep vein thrombosis superior to the popliteal vein
• •International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) results outside of normal range (INR 0.8-1.4; PTT 25-35 seconds)
• •Presence of a posterior fossa tumor or mass
• •Life expectancy \< 1 year
• •Currently participating in another investigational drug or device trial that could conflict with study data collection or follow-up
• •Pregnant
• •Unwilling or unable to comply with follow-up requirements