Anuncia Medical Receives FDA Breakthrough Device Designation for ReFlow® External Ventricular Drains (EVD)
Company Proudly Expands Cerebrospinal Fluid (CSF) Management and Critical Care Solutions Portfolio Along with Receiving Flinn Foundation Grant
Company Supporting Global and Local Initiatives Reducing the Impact of Hydrocephalus
SCOTTSDALE, Ariz., March 20, 2025 /PRNewswire/ — Anuncia Medical, Inc. (“Anuncia”), a pioneering company in CSF management and neurocritical care, has received Breakthrough Device Designation from the FDA for its ReFlow® EVD, an innovative solution for external ventricular drains (EVDs) used to manage brain swelling and elevated intracranial pressure. This milestone expands Anuncia’s breakthrough portfolio, complementing the ReFlow® System Mini, a first-generation device with up to six years of clinical success, and the ReFlow® Mini Flusher, already transforming hydrocephalus care in its early U.S. rollout by enabling noninvasive, at-home CSF flow maintenance and reducing the need for costly revision surgeries. With ReFlow® EVD, Anuncia is advancing both acute and long-term CSF management, driving innovation, and expanding strategic opportunities in neurocritical care.
ReFlow® EVD: Advancing ICU Care and Patient Outcomes
EVDs are placed in more than 100,000 cases annually in the U.S. to relieve elevated intracranial pressure. The ReFlow® EVD is the first device of its kind to provide a noninvasive, manual flushing mechanism designed to restore and maintain cerebrospinal fluid (CSF) flow. By reducing the risk of occlusions, it helps prevent prolonged ICU stays, additional neurosurgical procedures, and costly EVD replacements. Unlike traditional flushing methods that require a neurosurgeon, ReFlow® EVD can be operated by nurses noninvasively during routine patient checks, seamlessly integrating into existing workflows to improve efficiency and reduce 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.”
