Anuncia receives FDA breakthrough device designation for ReFlow System Mini

Anuncia

2 March 2021 - Anuncia received U.S. FDA breakthrough device designation for its ReFlow System Mini intended for the treatment of CSF disorders requiring shunting such as hydrocephalus, a debilitating and life-threatening condition affecting more than 1 million U.S. patients.

In a preliminary study of patients at risk for shunt occlusion by two US paediatric centres of excellence, all intracranial shunts remained patent beyond one year using prophylactic flushing with the current ReFlow System.

Read Anuncia press release 

Michael Wonder

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Michael Wonder