FDA grants breakthrough nod to Anuncia’s cerebral spinal fluid treatment

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 …

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