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The Alivio Ventricular Catheter and Flusher System) is for use in the treatment of patients with hydrocephalus, as components of a shunt system when draining of cerebrospinal fluid (CSF) is indicated. The Alivio Flusher may be used by a qualified clinician as a tool to facilitate a non-invasive retrograde fluid flush of the Alivio Ventricular Catheter to unblock inlet holes or open its relief membrane to restore or increase CSF flow in a non-flowing shunt. The Alivio Flusher is not intended to change standard care practices for diagnosis, treatment, or follow-up of patients with proximal catheter occlusions.

The Alivio System, consisting of the Alivio Flusher and Alivio Ventricular Catheter, is an implantable component of a CSF Shunt System used in the treatment of patients with Hydrocephalus. The Ventricular Catheter is implanted in the ventricle and connected distally to the Flusher, which is in turn connected to a commercially available flow regulating valve (not provided as part of the Alivio System). Similar to manual pumping of a flow requlating valve or performing an invasive shunt tap via the flow regulating valve; the Alivio Flusher, a fluid reservoir, may be used by a qualified clinician as a tool to facilitate a noninvasive retrograde fluid flush to the Alivio Ventricular Catheter to unblock occluded, proximal inlet holes. If the inlet holes are not able to be unblocked, the retrograde fluid flush will open the relief membrane of the Alivio Ventricular Catheter, creating a new fluid pathway to restore or increase CSF flow in a non-flowing shunt with occluded inlet holes. Once the relief membrane has been used to restore flow in a non-flowing shunt, subsequent retrograde fluid flushing of the Alivio Ventricular Catheter with the Alivio Flusher may not be sufficient to reopen the relief membrane, which may become occluded similar to proximal catheter inlet holes. After flushing the device, standard methods of care should be used to determine that the reservoir is refilled prior to flushing a second time. Similar to commercially available reservoirs used in shunt systems, refilling of the Flusher reservoir can be confirmed by palpation of the dome. Repeated flushing of the device with an empty reservoir may not be effective. The clinician must use his/her medical judgment and standard practice at his/her institution to care for the patient pre, during, and post utilization of the Alivio System. The Alivio Flusher does not requlate flow of the shunt system. A flow requlating shunt valve is not provided with the Alivio System. During passive fluid from the ventricular catheter flows freely, without restriction through the passive flow channel of the Flusher. The Alivio System is compatible and has been tested with the Integra Contour-Flex™ Valve. The Alivio System is designed to be compatible with all commercially available flow requlating valves with standard inlet connectors, similar to the integra "Contour-Flex"" Valve.