Pilot Study to Evaluate the Safety and Effectiveness of the CereVasc eShunt™ System in the Treatment of Communicating Hydrocephalus
The eShunt™ System is a minimally invasive method of treating communicating hydrocephalus. The eShunt System includes a proprietary eShunt Delivery System and the eShunt Implant, a permanent implant deployed in a minimally invasive, neuro-interventional procedure. The eShunt Implant is designed to drain excess cerebrospinal fluid (CSF) from the intracranial subarachnoid space (SAS) into the venous system.
• Age \> 18
• Subject provides Informed Consent (IC)
• Post-aneurysmal SAH with Hunt and Hess Grades I-IV with EVD in place with the need for a permanent CSF shunt determined through a failed EVD clamping trial defined as:
‣ Post-clamping ICP of \> 20 cmH2O for 15 min, or
⁃ Post-clamping ICP \> 25 cmH2O for \< 15 min with patient intolerance to EVD clamping
⁃ Post-clamping ICP \>15 cmH2O for 15 min with radiographic evidence of ventriculomegaly
• Clinical signs and symptoms of communicating hydrocephalus
• Neurologically stable without evidence of severe vasospasm
• Pre-procedure MRI with gadolinium confirmation of IPS (inferior petrosal sinus) and CPA (cerebellopontine angle) cistern anatomy suitable for eShunt Implant deployment as confirmed by SSC (subject screening committee)
• Pre-procedure CT confirmation of no obstruction preventing CPA cistern access at target implant site (e.g., petrous bone) as confirmed by SSC