Comprehensive Engineering Performance Evaluation of the IRRAflow Active Fluid Exchange System with IRRAS Bolt for Intracranial Fluid Management

The IRRA<i>flow</i> Active Fluid Exchange System (IRRAS, San Diego, California, USA) is a novel medical device designed to manage intracranial pressure (ICP) and cerebrospinal fluid (CSF) in patients with neurological conditions such as subarachnoid hemorrhage (SAH), intraventricular hemorrhage (IVH), and chronic subdural hematoma (cSDH). This study presents a series of evaluations assessing the system's performance across multiple technical aspects: catheter-bolt sealing, catheter liquid flow characterization with bolt fixation, torque limit evaluation of the metal bolt and plastic wing interface, fluid equilibrium, injection volume accuracy, 24-hour pressure drift evaluation of IRRA<i>flow</i> ICP sensor output, and pressure accuracy. The results are reported relative to predefined acceptance criteria for each test. The engineering and potential clinical implications of these findings are described in the context of intracranial fluid management.