Device Dossier

M.scio Flat Implant with distal catheter - Cerebrospinal fluid shunt sensor/reservoir

Device Dossier for M.scio Flat Implant with distal catheter - Cerebrospinal fluid shunt sensor/reservoir (Cerebrospinal fluid shunt sensor/reservoir,…

Intended purpose

It is used for intracranial pressure measurement within the cerebrospinal fluid (CSF); it measures intracranial pressure, diverts CSF to manage elevated pressure. It is not designed for puncture or external infusion/injection/drainage.

Functional description

The M.scio Flat implant is a ICP active implantable medical device designed for integration into a shunt. It is used when a patient’s skull anatomy lacks sufficient space. The measuring cell, housed in the reservoir, has a pressure-sensitive membrane facing the ventricle. Measurement data is collected electronically, read out telemetrically, displayed on the Reader Unit Set, and stored on an SD card for analysis.

TGA Public Summary