Our Technology - Anuncia

Our Technology

The ReFlow™ System Mini and the ReFlow™ Mini Flusher offer the only noninvasive technology to restore, increase, or maintain flow in a shunt system.

Our technology was developed through engagement with hydrocephalus experts, the broader scientific community, as well as patients and families.

When added as a component in a shunt system, the ReFlow™ Mini is designed to address one of the most common problems in hydrocephalus: ventricular catheter occlusions (blockages).

What’s Included with The ReFlow™ System Mini

The ReFlow™ System Mini has a “Flusher” component and a specially designed Ventricular Catheter. The ReFlow™ Mini Flusher component may also be sold separately (without the ReFlow™ Ventricular Catheter).
The ReFlow™ Mini Flusher is added into a shunt system. On one side, it connects directly to the shunt ventricular catheter (either the ReFlow™ Ventricular Catheter or other commonly available ventricular catheters). On the other side, the ReFlow™ Mini Flusher connects to a pressure controlled / flow regulating valve (commonly available, not included). All shunt system components, including the ReFlow™ Mini components, are implanted under the scalp.
The ReFlow™ Mini Flusher works with shunt valves, the ReFlow™ Ventricular Catheter, and other ventricular and distal catheters of most makes and models.

How The ReFlow™ System Mini Is Used

When there is CSF flow or the shunt is functioning normally, the ReFlow™ Mini Flusher is passive and cerebrospinal fluid (CSF) from the ventricular catheter flows freely through the flusher component to the shunt valve. A deliberate press of the ReFlow™ Mini Flusher by a trained user sends a small, controlled flush of fluid toward the ventricular catheter in an effort to push out any blockages to open ventricular catheter flow holes and restore or maintain CSF flow.
If using the ReFlow™ Ventricular Catheter, and flow holes remain blocked, the flush opens its ’emergency relief membrane’ to make an additional fluid pathway and re-establish flow.

CAUTION: Flushing of the device is only intended to be performed under the supervision of the treating physician. Do not attempt to flush the device unless you have been trained and instructed to do so by and under the care of the treating physician who has been trained and understands the use of the ReFlow™ Ventricular Catheter and ReFlow™ Mini Flusher. Flushing shall only be performed as directed by the treating physician and under their care and guidance.

WARNING: The ReFlow™ System Mini and ReFlow™ Mini Flusher are not intended to change what you should do if you are experiencing symptoms of a ventricular catheter blockage or shunt failure. Contact your physician or seek medical help if you are experiencing any symptoms of system or component failure, the flusher dome has a noticeable resistance to compression and cannot be depressed, or the flusher dome does not refill.

Images for illustrative purposes only and may not be representative of the ReFlow™ Mini Flusher’s ability to clear blockages.

What does this mean for patients with shunts?

Emergency shunt revision surgery to address a blocked ventricular catheter is one of the most common problems in the treatment of hydrocephalus.
The ReFlow™ System Mini and the ReFlow™ Mini Flusher provide a noninvasive action to potentially restore, maintain, or increase shunt system flow – without surgery.
This system represents a first step toward a new generation of products with advanced technological features for use in treatment of hydrocephalus and other CSF disorders. The ReFlow™ System Mini is engineered to empower clinicians, patients, and families in the treatment of hydrocephalus to help break the shunt malfunction cycle and emergency shunt revision surgeries.
Anuncia is continuing to expand our platforms to further impact the treatment of hydrocephalus.

Contact your physician to discuss if the ReFlow™ System Mini may be right for you.

Additional information about the ReFlow™ System Mini is available by contacting Anuncia.

(978) 942-5600 | [email protected]

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6908 E Thomas Road
Suite 302
Scottsdale, AZ 85251

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Disclaimer

The ReFlow™ System Mini and ReFlow Mini Flusher are FDA cleared for use in the treatment of patients with hydrocephalus or conditions where draining or shunting of cerebrospinal fluid (CSF) is medically indicated. The ReFlow™ System Mini and ReFlow™ Mini Flusher are not for everyone; please consult your doctor. The ReFlow™ System Mini and ReFlow™ Mini Flusher are only available in the United States. The ReFlow™ System Mini and ReFlow™ Mini Flusher are prescription devices sold by or on the order of a physician.

Caution: FDA (USA) law restricts this device to sale by or on the order of a physician. Refer to product package insert for instructions, warnings, precautions and complications.

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