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.”