Device Dossier
M.scio Dome Implant - Cerebrospinal fluid shunt sensor/port/reservoir
Device Dossier for M.scio Dome Implant - Cerebrospinal fluid shunt sensor/port/reservoir (Cerebrospinal fluid shunt sensor/port/reservoir, Class III,…
- GMDN category: Cerebrospinal fluid shunt sensor/port/reservoir
- Sponsor: B Braun
Intended purpose
It is used for intracranial pressure measurement within the cerebrospinal fluid (CSF); it measures intracranial pressure, allows for hypodermic infusion/injection of materials, drains cerebrospinal fluid (CSF), and diverts CSF to manage elevated pressure. It has a polymer puncturable dome.
Functional description
The M.scio Dome is an active implantable device that integrates into a shunt, functioning as a conventional reservoir. Its measuring cell, housed in the reservoir, has a pressure-sensitive membrane facing the ventricle. Measurement data is collected electronically, read out telemetrically, displayed non-invasively on the Reader Unit Set, and stored on an SD card for user analysis.