Intracranial Pressure–Monitoring Device Receives Breakthrough Device Designation for Hydrocephalus

The Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the M.scio System (Aesculap, Center Valley, PA; Miethke, Potsdam, Germany), expediting the device’s development for managing and improving care for individuals with hydrocephalus. The M.scio System consists of a small implantable sensor that is integrated into a shunt system or used as a standalone intracranial pressure (ICP) monitor. It enables continuous, long-term  telemetric pressure measurement, which according to a statement released by Miethke, will potentially reduce the need for time-consuming and costly examinations, procedures, and hospitalizations. 

According to a statement by Christopher Miethke, CEO of Miethke, “The M.scio System is designed to provide an alternative treatment option to the currently available ICP monitoring modalities. In this way, the M.scio System is designed to guide both surgical as well as medical treatment and optimize patient management.”