Novel Noninvasive Flushing System Used by Patients
SCOTTSDALE, Ariz., May 23, 2023 /PRNewswire/ -- Anuncia Medical Inc. ("Anuncia" or the "Company"), a company specializing in advancing innovations for implantable and external cerebrospinal fluid (CSF) management systems and neurocritical care, is pleased to announce that an article highlighting its FDA cleared and CE Marked ReFlow™ Ventricular System "Gen 1" with Hydrocephalus shunts in patients suffering from chronic shunt occlusions, has been published in Pediatric Neurosurgery. Two years prior to being implanted with the ReFlow™ System, 7 of the 9 patients represented in the publication experienced a combined total of 14 proximal shunt failures that required revision. In the 2-4 years following ReFlow™ implantation and use to maintain flow, only 1 proximal shunt failure occurred amongst the 9 patients. As revisions are typically associated with expensive hospital admissions for both the child and family, reducing the number of revisions needed is invaluable to those impacted.
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.
"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 potentially prevent the occlusion in the first place," said Dr. Ramin Eskandari MD, pediatric neurosurgeon from Medical University of South Carolina. "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 data, and others like them, suggest that use of the ReFlow device to maintain flow at home may also have potential benefits as a preventative treatment that could reduce revision surgeries. Anuncia received a U.S. Food and Drug Administration (FDA) "Breakthrough Device Designation" for this use and is working closely with the medical community and the FDA to design and conduct clinical trials to further evaluate this practice.
"Three years ago, Dr. Eskandari suggested the ReFlow device be implanted with my son's shunt hoping that it would prevent future complications and surgeries. We were prescribed a daily "maintenance" regimen to flush Mark's ReFlow device at home and it was not uncomfortable for him. In fact, it helped my son learn to count. The device provides us with confidence and a degree of control over his hydrocephalus. Mark is now five and thus far, it has worked like a charm. Mark has not had a single surgical intervention. The ReFlow is a brilliantly simple device that is very easy to use. We're grateful," shared Hillary, the mother of a young hydrocephalus patient treated with the ReFlow™ "Gen 1" by Dr. Eskandari.
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 ReFlow System Mini, represent almost a decade of work with hydrocephalus clinical experts and talented engineers," shared Elsa Chi Abruzzo, President & 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 Anuncia Medical Inc.
Anuncia Medical is a neurological device company solving the large unmet needs in cerebrospinal fluid (CSF) management and neurocritical care through clinically validated, noninvasive, cost-effective, 'breakthrough' technologies designed to monitor and treat patients at home, or in clinic. Anuncia aims to empower patients in their care journey and provide peace of mind. Built on a commitment to high-quality standards, evidence-based medicine, and strong ethical behavior for almost a decade, Anuncia Medical Inc. is a trusted partner for neurosurgeons. For more information, visit www.AnunciaMedical.com, and follow Anuncia on LinkedIn and Twitter.
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 noninvasively pressing on the flusher dome. It is designed to 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.
SOURCE Anuncia Medical, Inc.