Anuncia Medical Inc. announced the distribution of the ReFlow™ Mini Flusher at several leading neurosurgical centers across the United States to help prevent hydrocephalus shunt occlusions in patients with hydrocephalus or similar conditions.1
Hydrocephalus is a chronic neurologic condition where excess cerebrospinal fluid (CSF) accumulates in the brain, causing severe symptoms, hospitalizations, and death if left untreated.1 To prevent accumulation of CSF, the majority of patients with hydrocephalus will often undergo the implantation of a ventriculoperitoneal shunt. However, this shunt is commonly occluded by debris, protein, and cellular ingrowth, which causes malfunctions and requires repeated surgeries to clear the occlusion.
The ReFlow Mini Flusher system is designed to flush the patient’s CSF back into the ventricular catheter to maintain the shunt and prevent occlusion. The prophylactic use of this device may reduce the high rate of shunt malfunctions due to catheter occlusions and decrease repeat revision brain surgeries.
The distribution of this device is supported by a 2023 study published in the Journal of Pediatric Neurosurgery on the first generation ReFlow system2. Researchers enrolled 9 patients with hydrocephalus shunts who suffer from chronic shunt occlusions. Two years prior to implanting the ReFlow system, 7 of the 9 patients experienced a combined total of 14 proximal shunt failures that required revision surgery. In the 2 to 4 years after implantation, only 1 proximal shunt failure occurred among the 9 patients.
“Adding a ReFlow component to non-invasively clear a clogged shunt, and even prevent the blockage, may dramatically change shunt failure rates and help shunted patients get back to leading normal lives,” Ramin Eskandari MD, chief of pediatric neurosurgery at Medical University of South Carolina, said in a news release.3
The ReFlow Mini Flusher has received clearance from the US Food and Drug Administration (FDA).
- Anuncia medical successfully launches second generation device to treat hydrocephalus at several leading neurosurgical centers across the United States. News release. PR Newswire. July 26, 2023 Accessed July 26, 2023. https://www.prnewswire.com/news-releases/anuncia-medical-successfully-launches-second-generation-device-to-treat-hydrocephalus-at-several-leading-neurosurgical-centers-across-the-united-states-301886225.html
- Vinzani M, Alshareef M, Eskandari R. Use of a prophylactic retrograde-flushing device in high-risk pediatric patients with ventriculoperitoneal shunts: a technical note. Pediatr Neurosurg. Published online May 5, 2023. https://doi.org/10.1159/000530869
- Anuncia medical inc. announces published data with promising clinical outcomes using the ReFlow™ ventricular system in-line with hydrocephalus shunts. News release. PR Newswire. May 23, 2023. Accessed July 26, 2023. https://anunciamedical.com/anuncia-medical-inc-announces-published-data-with-promising-clinical-outcomes-using-the-reflow-ventricular-system-in-line-with-hydrocephalus-shunts/