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

This is a prospective, non-randomized, open-label, single-center, pilot study in subjects with normal pressure hydrocephalus for whom a traditional CSF shunt implant is indicated.

Up to 30 subjects will receive the eShunt Implant at one investigational site. Subjects will return for five follow-up visits in the first year and then continue to attend visits every six months for five years post-implantation.

The study objectives are to demonstrate safety of the eShunt Procedure, as well as demonstrate safety and efficacy of the eShunt Implant in a small sample of patients.

Subjects will be followed long-term; primary analysis results will be used to support additional studies.

Inclusion criteria

• Patients 65-85 years old and traditional CSF shunt placement is indicated based upon a diagnostic NPH evaluation
• Patient is able and willing to provide written informed consent
• History or evidence of gait impairment duration ≥6 months
• Clinical presentation consistent with NPH including 2 or more of the clinical triad (i.e., history of gait disturbance, progressive mental deterioration, and urinary urgency or incontinence), together with:

• Brain MRI signs of ventricular enlargement disproportionate to cerebral atrophy (Evans Index >0.3) and the absence of severe hippocampal atrophy
• Pre-procedure spinal tap test with subsequent gait disturbance improvement (Timed Up and Go Test) of at least 20%
• CSF opening pressure ≥10 cmH2O
• Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12
• Pre-procedure MRI confirmation of anatomy suitable for eShunt Procedure, as described in Section 1.8.3.4.2 and confirmed by SSC
• Pre-procedure CT confirmation of anatomy suitable for eShunt Procedure, as described in Section 1.8.3.4.2 and confirmed by SSC

Exclusion criteria

• Unable to walk 10 meters (33 feet) with or without an assistive device
• Conditions impairing gait that are considered to be unrelated to hydrocephalus
• 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
• 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
• Other medical illnesses that may cause the patient to be non-compliant with the protocol or confound data interpretation
• Pregnant or planning to become pregnant
• Unwilling or unable to comply with follow-up requirements