Anuncia Medical, Inc., Announces Published Data with Clinical Outcomes Using the ReFlow™ Ventricular System In-Line with Hydrocephalus Shunts
Noninvasive Flushing System Used by Patients
Anuncia Medical, Inc., a company advancing innovations for cerebrospinal fluid (CSF) management systems and neurocritical care has published an article in the journal Pediatric Neurosurgery reporting the use of the ReFlow™ Ventricular System with Hydrocephalus shunts in patients suffering from chronic shunt occlusions.
Hydrocephalus is an abnormal accumulation of CSF in the brain, causing increased intracranial pressure (ICP). Yearly, tens of thousands of adults and children with hydrocephalus undergo revision surgeries at U.S. hospitals to replace occluded shunts. These repeat brain surgeries and hospitalizations cause significant undue emotional, health, and economic burden to patients and families worldwide. From May 2018 to March 2020, the 510(k) Cleared and CE Marked “Gen 1” ReFlow device was implanted in over 30 patients. Nine of those patients were represented in the publication. The authors report a total of 14 shunt revisions in the 2 years prior to the implant of the ReFlow System, to only 1 revision in the 2.8-4 years following ReFlow device implantation and use to maintain CSF flow in the shunt.
“The failure rate of shunts after implantation is unacceptably high, with most failures happening from occlusion/clogging of the ventricular catheter. Historically, patients had only one option when this occurred, and that was brain surgery, risking brain hemorrhage and shunt infections. Surgeons have never been able to non-invasively open an occluded catheter, let alone prevent the occlusion in the first place,” said Dr. Ramin Eskandari MD, a pediatric neurosurgeon from Medical College of South Carolina who was involved in the study. “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”.
Though limited, these recently published results, and others like them, suggest the use of the ReFlow device, to maintain flow at home, may have potential benefits as a preventative treatment that could reduce revision surgeries. Further studies and data are needed to confirm these results, but the Hydrocephalus Association is excited to follow this progress.
Anuncia received a U.S. Food and Drug Administration (FDA) “Breakthrough Device Designation” for this use and is working closely with the medical community, the Hydrocephalus Association, and the FDA to design and conduct important clinical trials to further evaluate this practice.
With >4 years of clinical follow-up and feedback from the ReFlow “Gen 1” device, Anuncia Medical has developed a smaller, easier-to-use ReFlow System Mini “Gen 2” device. Launching in the U.S. next month, the ReFlow System Mini represents the future of hydrocephalus management by providing an easy, and noninvasive way to potentially clear occlusions and/or maintain CSF flow in a shunt, by simply pressing the soft flusher dome located under the patient’s scalp. When pressed, the ReFlow Mini Flusher sends a small, controlled amount of fluid toward the ventricular catheter to unblock the catheter’s flow holes. This small component may be added in little time to the shunt system during a standard implantation or revision procedure.
“The ReFlow ‘Gen 1’ and the smaller, improved ReFlow System Mini, represent almost a decade of work with hydrocephalus clinical experts and talented engineers,” shared Elsa Chi Abruzzo, CEO of Anuncia Medical. We look forward to these continued partnerships in a community dedicated to improving the care, and lives, of all patients living with hydrocephalus.”
About ReFlow™ System Mini and ReFlow™ Mini Flusher
The ReFlow™ System Mini represents a platform technology designed to improve the function of CSF management devices in the OR, the ICU, and at-home. The ReFlow™ System Mini and ReFlow™ Mini Flusher are 510(k) cleared by the U.S. FDA for use in the treatment of hydrocephalus as a part of a CSF shunt system. The ReFlowTM System Mini is a small, implanted system consisting of a flushing device and ventricular catheter. When implanted in line with a commercially available shunt, it can be actuated by pressing on the flusher dome, noninvasively. It is designed to selectively deliver a small amount of fluid toward the ventricular catheter, for restoration, increase, or maintenance of flow, by clearing catheter flow holes. The implanted ReFlow™ Mini Flusher is meant to be actuated by trained users, in clinical or non-clinical settings, at the personalized direction and supervision of the patient’s physician.
Patients are advised to consult with a qualified healthcare professional to determine if this product is right for them. Important Safety Information & Risks: For Indications for Use, Warnings, Precautions, and other safety information, please refer to product labeling.
Read the journal publication here.
To learn more, read the press release.