Anuncia Medical has announced that an article highlighting its US Food and Drug Administration (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, seven of the nine 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 one proximal shunt failure occurred among the nine patients.
Because 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, as detailed by an Anuncia press release.
“The failure rate of shunts after implantation is unacceptably high, with most failures happening from occlusion/clogging of the ventricular catheter,” said Ramin Eskandari (Medical University of South Carolina, Charleston, USA). “Historically, patients had only one option when this occurred, and that was brain surgery, risking brain haemorrhage 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. 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, the release continues. Anuncia received a US 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.
With more than four years of clinical follow-up and feedback from the ReFlow device (Gen 1), Anuncia has developed a smaller, easier-to-use ReFlow system mini device (Gen 2). Launching in the USA in June 2023, the ReFlow system mini represents “the future of hydrocephalus management”, according to the company, providing an easy and non-invasive way to potentially clear occlusions and/or maintain cerebrospinal fluid (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 minimal 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,” said Elsa Chi Abruzzo, president and CEO of Anuncia. “We look forward to these continued partnerships in a community dedicated to improving the care, and lives, of all patients living with hydrocephalus.”