Anuncia Medical has announced the successful first implant of the company’s US Food and Drug Administration (FDA)-cleared ReFlow mini flusher device.
Performed on by neurosurgeon Samuel Cheshier (Intermountain Primary Children’s Hospital, Salt Lake City, USA), the patient previously required at least 11 brain surgeries to manage their hydrocephalus—a chronic neurological condition in which excess cerebrospinal fluid (CSF) accumulates in the brain, often causing severe symptoms, frequent hospitalisations and ongoing health concerns.
“Neurosurgeons treating hydrocephalus have been waiting too long for a non-surgical option to help keep implanted shunts flowing,” Cheshier said. “The ReFlow is easy to implant with my preferred shunt type and just makes sense. I welcome having this tool in my toolkit.”
The second-generation, FDA-cleared ReFlow mini flusher is indicated for use in patients living with hydrocephalus or similar conditions. The reduced size and profile of the technology is designed to better support a broader hydrocephalus patient population, from infants to older adults, as per an Anuncia press release.
Used in line with any shunt system brand, the ReFlow mini flusher is designed to flush the patient’s CSF back into the ventricular catheter to maintain, restore or increase hydrocephalus shunt flow with just a simple finger depression of the flusher’s soft dome located beneath the patient’s scalp. Non-invasive flushing with the ReFlow mini flusher can be performed in-clinic by trained clinical staff, or anywhere by a trained patient/caregiver as directed by the neurosurgeon.
The first-generation ReFlow device was successfully implanted in more than 30 patients with hydrocephalus and is the subject of 11 clinical studies/reports in total. In May this year, a study on the improved outcomes of nine ReFlow patients was published in Pediatric Neurosurgery. And, after successfully launching in June 2023, the ReFlow mini flusher is now being shipped to leading institutions for use by some of the most well-respected neurosurgeons in the USA, Anuncia claims. It is also expected that the ReFlow mini flusher will be available internationally in the future.
“I have had five shunt revision surgeries due to catheter occlusions and can attest to the anguish and frustration of patients, and their families,” said Anuncia’s new vice president of sales and marketing Mark Geiger, who has hydrocephalus. “The ReFlow mini flusher developed off the ‘Gen 1’ platform, with a decade of work and recently published clinical data with four-plus years of follow-up, may profoundly impact hydrocephalus patients by providing control and confidence through non-invasive ventricular catheter flushing at home to restore and maintain CSF flow.”