Brain swelling and intracranial pressure management device gets FDA designation

Brain swelling management device receives FDA designation: ©Stockdevil - stock.adobe.com

Anuncia Medical Inc., a leader in cerebrospinal fluid (CSF) management and neurocritical care, has received Breakthrough Device Designation from the U.S. Food and Drug Administration for its ReFlow EVD, a novel external ventricular drain (EVD) designed to manage brain swelling and elevated intracranial pressure.

This milestone expands Anuncia's portfolio of CSF management solutions, complementing its ReFlow System Mini and ReFlow Mini Flusher, both of which have demonstrated success in hydrocephalus care. With the introduction of ReFlow EVD, Anuncia is enhancing acute neurocritical care by improving the reliability and efficiency of EVDs used in intensive care units.

A novel approach to managing intracranial pressure

More than 100,000 EVD procedures are performed annually in the U.S. to relieve elevated intracranial pressure, a common issue in patients with traumatic brain injuries, strokes, and other neurological conditions. The ReFlow EVD is the first device of its kind to incorporate a noninvasive, manual flushing mechanism that helps restore and maintain CSF flow. By reducing the risk of occlusions, it has the potential to prevent prolonged ICU stays, additional neurosurgical interventions, and costly EVD replacements.

Unlike traditional flushing methods that require a neurosurgeon, the ReFlow EVD's design allows nurses to perform noninvasive flushing as part of routine patient care, streamlining workflows and reducing costs.

"This regulatory milestone highlights the broader impact of our ReFlow innovation beyond hydrocephalus management," said Elsa Chi Abruzzo, CEO and president of Anuncia Medical. "We continue to hear from neurosurgeons, nurses, patients, and families that ReFlow's simple, seconds-long manual flush helps prevent blockages—improving outcomes and providing peace of mind. Expanding our ReFlow portfolio reinforces our commitment to advancing neurocritical care and patient well-being."

Expanding hydrocephalus care through research and global partnerships

Beyond neurocritical care, Anuncia continues to drive innovation in hydrocephalus treatment. The company recently secured funding from the Flinn Foundation's Bioscience Entrepreneurship Program to support post-FDA clearance studies on the ReFlow Mini Flusher. Led by Jason Hauptman of Phoenix Children's Hospital and Anthony Avellino of HonorHealth Medical Group, the research aims to generate critical clinical evidence for hydrocephalus patients at high risk of shunt occlusion, including those affected by Coccidioidomycosis (Cocci) Meningitis, a serious complication of Valley Fever.

"This grant allows us to generate the high-quality, prospective clinical data needed for broader commercial adoption, further cementing Arizona as a leader in neurosurgical excellence," said Avellino. "By partnering with Dr. Jason Hauptman, chief of neurosurgery at Phoenix Children's, we are advancing hydrocephalus care while showcasing Arizona's world-class institutions as a national model."

Recognizing the global disparities in hydrocephalus treatment, Anuncia has also partnered with NeuroKids.org to expand access to care in underserved regions such as Zambia, Kenya, and Uganda. The collaboration aims to address the urgent need for CSF management solutions in areas where post-infectious hydrocephalus remains a major health challenge.

"Anuncia Medical's revolutionary ReFlow device has the power to provide peace of mind to parents and patients living with hydrocephalus," said Derek Johnson, CEO of NeuroKids.org. "NeuroKids is proud to partner with Anuncia Medical to bring this technology to some of the most vulnerable populations living in Africa."