Neurological device company Anuncia Medical has commercially introduced the second-generation device, ReFlow Mini Flusher in the US.
Approved by the US Food and Drug Administration (FDA), the device is intended for the treatment of hydrocephalus or similar conditions at several neurosurgical centres across the country.
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A chronic neurological condition, hydrocephalus occurs due to an excess accumulation of cerebrospinal fluid (CSF) in the brain.
With a reduced size and profile, the new device supports a wider range of hydrocephalus patients, from infants to older adults.
A patented device, the ReFlow Mini Flusher can be used with any shunt system brand.
Its unique design allows it to flush the CSF back into the ventricular catheter, thereby helping to maintain, restore or increase hydrocephalus shunt flow, just with the push of the soft dome of the flusher placed beneath the patient’s scalp.
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By GlobalDataAnuncia Medical CEO and president Elsa Chi Abruzzo said: “Today is an important milestone as the company begins to meet the needs of neurosurgeons who have been waiting since the start of the Covid pandemic for our ReFlow Mini Gen 2 device to become available.”
According to the data published in the Journal of Pediatric Neurosurgery on the first-generation ReFlow device, its use may cut down the high rate of shunt malfunctions because of catheter occlusions and related repeat revision brain surgeries.
ReFlow has been granted breakthrough designation by the FDA and the company plans to further investigate it in future clinical studies.
