Anuncia announced today that it received FDA breakthrough device designation for its ReFlow system for cerebral spinal fluid (CSF) management.
Lowell, Mass.-based Anuncia’s ReFlow Mini is intended to treat CSF disorders requiring shunting, including hydrocephalus, according to a news release. It has been optimized to serve a broad hydrocephalus population, including infants with non-communicating hydrocephalus, young women with pseudotumor cerebri and older patients with communicating, idiopathic normal pressure hydrocephalus.
Breakthrough designation for Anuncia’s technology would allow in-clinic or at-home prophylactic flushing performed in a non-invasive manner by trained patients, caregivers and clinicials to potentially prevent CSF blockages.
A preliminary study of patients at risk for shunt occlusion performed by two U.S.-based pediatric centers observed that all intracranial shunts remained patent beyond one year of using prophylactic …