Anuncia Medical’s ReFlow System Mini Cleared

The FDA has granted marketing clearance to Anuncia Medical’s ReFlow System Mini for treatment of patients with hydrocephalus and other cerebrospinal fluid disorders that require shunting.

The ReFlow system features a flusher that connects directly to a ventricular catheter. They are implanted under the scalp and connected to a flow regulating shunt valve — which is not supplied with the system.

The equipment is used to noninvasively flush the catheter to restore, increase or maintain cerebrospinal fluid flow in a shunt, the company said.

The Scottsdale, Ariz.-based company is focused on developing devices for cerebrospinal fluid management and neurocritical care.