Anuncia Medical Announces the First Successful US Implant of the Company’s Newly Commercially Released ReFlow™ Mini Flusher Device for Hydrocephalus Patients
Intermountain Primary Children’s Hospital First in the Country to Implant this Next Generation FDA-Cleared Device
Company Welcomes Vice President of Sales & Marketing, Mark Geiger, Who Lives with Hydrocephalus
SCOTTSDALE, Ariz., August 1, 2023 – 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 the successful first implant of the Company’s FDA-cleared ReFlow™ Mini Flusher device.
Performed by neurosurgeon Samuel Cheshier, MD, at Intermountain Primary Children’s Hospital in Salt Lake City, the patient previously required at least 11 brain surgeries to manage their hydrocephalus, a chronic neurological condition in which excess CSF accumulates in the brain, often causing severe symptoms, frequent hospitalizations, and ongoing health concerns.
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.
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. Noninvasive 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 over 30 patients with hydrocephalus and is the subject of 11 clinical studies/reports. In May, a study on the improved outcomes of 9 ReFlow patients was published in Pediatric Neurosurgery. Patients with hydrocephalus often experience repeat brain surgeries because their shunts become occluded with tissue and cells in the CSF within cavities, or ventricles, of the brain. These obstructions prevent the shunt from working, resulting in increased intracranial pressure (ICP) that can cause brain damage or even death if left untreated.
The first neurosurgeon to implant the new ReFlow Mini Flusher, Dr. Cheshier from the University of Utah Health and Intermountain Primary Children’s Hospital, reported “Neurosurgeons treating hydrocephalus have been waiting too long for a non-surgical option to help keep implanted shunts flowing. The ReFlow is easy to implant with my preferred shunt type and just makes sense. I welcome having this tool in my toolkit.”
“I’ve had five shunt revision surgeries due to catheter occlusions and can attest to the anguish and frustration of patients and their families,” reported Anuncia Medical’s new Vice President of Sales & 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 4 plus years of follow-up, may profoundly impact hydrocephalus patients, by providing control and confidence, through noninvasive ventricular catheter flushing at home, to restore and maintain CSF flow.”
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 United States. It is expected that the ReFlow Mini Flusher will be available internationally in the future.
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 that are 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, Twitter, Facebook, and Instagram.
About ReFlow™ System Mini and ReFlow™ Mini Flusher
Available in the U.S. only, 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. The ReFlow™ System is a prescription device sold by or on the order of a 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.
