The ReFlow™ Ventricular System was created with a singular focus: to develop better solutions for patients with Hydrocephalus.
The ReFlow™ Flusher, located under the scalp as with a CSF shunt regulator valve, will be connected directly to the ReFlow™ Ventricular Catheter at the proximal barb and connected to a shunt regulating valve (not included) at the distal end. The ReFlow™ System is designed to work with valves (programmable and non-programmable) and abdominal catheters of any make or model.
The Flusher component is designed to provide a non-surgical means to restore or improve flow through the shunt system. In the case of completely obstructed flow through the shunt, it will provide a non-invasive means to open the relief membrane in the catheter and restore ventricular drainage.
The Reflow™ Flusher itself does not regulate flow of the shunt system. The Reflow™ Flusher was developed to be compatible with all shunt valves with standard connections. During passive flow, fluid from the ventricular catheter flows freely, without restriction through the passive flow channel of the Flusher. For instruction on pressure and flow regulation, please refer to the IFU that is provided with the flow regulating shunt valve.
During flushing, the passive channel is manually occluded to create temporary one-way flow into the ventricular catheter. After a controlled and limited fluid pulse is sent from the flusher and the dome is released, the flush dome refills with CSF from the ventricular catheter and resumes free flowing fluid through the passive flow channel.
In the case of completely obstructed flow through the shunt, the Reflow™ System offers the neurosurgeon a non-invasive means to flush the ventricular catheter. At the neurosurgeon's discretion, retrograde flushing of the ventricular catheter can be performed by depression of the flush dome, which sends a controlled and limited pulse of fluid (CSF, or sterile saline introduced from priming procedure before implant) into the ventricular catheter. In the case of a severely occluded catheter, the relief membrane of the Reflow™ Ventricular Catheter opens to restore antigrade flow in the shunt system. The Reflow™ Membrane is a part of the proximal area of the catheter, and it is kept intact during implantation.
The ReFlow™ Ventricular System is not available for commercial use. The ReFlow™ Ventricular System is pending 510 (k) clearance from the U.S. Food and Drug Administration, and CE Marking.