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 flushing with the current ReFlow system, while more than half of the patients are nearing a two-year, occlusion-free shunt anniversary.
“Our team is very pleased to achieve this significant milestone making the ReFlow system Mini eligible for prioritized FDA regulatory review and Centers for Medicare and Medicaid (CMS) Medicare Coverage of Innovation Technology (MCIT) reimbursement review,” Anuncia president Elsa Abruzzo said in the release.
The ReFlow system was embedded beneath the scalp of the unidentified hydrocephalus patient and, with its subcutaneous “flusher” component and a ventricular catheter, the device used a “relief membrane” backup feature at the catheter’s proximal end. By pushing a button on the device, the first-in-human procedure cleared a clogged shunt that directs the flow of cerebrospinal fluid to the patient’s abdomen.