Photo courtesy of B. Braun
Australian regulators have made their first approval of a medical device for monitoring intracranial pressure as part of hydrocephalus management.
M.scio has been included in the Australian Register of Therapeutic Goods as a class III medical device indicated for use in hydrocephalus patients of all ages. It is developed by German company Miethke and exclusively distributed by B. Braun.
HOW IT WORKS
The sensor-based device, roughly the size of a coin, is implanted along the shunt tubing at the burr hole site. It has a compressible silicone membrane that responds to changes in cerebrospinal fluid (CSF) pressure, detected by a measuring cell and transmitted telemetrically to a hand-held receiver for live monitoring.
The sensor implant has a 44 hertz sampling rate, providing detailed pressure curves and clinically relevant intracranial pressure morphologies for both acute and long-term care. Its readings, according to B.Braun, remain stable with minimal drift (less than 2 mmHg) for up to four years.
In an interview with Mobihealth News, Magda Bennett, communications manager at B. Braun Australia, explained that the surgical implantation of M.scio is very similar to implanting a conventional shunt reservoir; they only require device‑specific guidance on handling and placement. Additional training, Bennett said, focuses mainly on how to review and interpret the data captured by the device. B. Braun is developing webinars and online modules to support clinicians in understanding workflow and analysing data.
When asked how it differs from conventional intracranial pressure monitoring approaches, Bennett said that M.scio is fully implanted under the skin with no external components. "Traditional intracranial pressure monitoring usually involves an external drain or device connected to a transducer or monitor, and patients typically need to remain in an intensive care setting while it is in place."
According to B. Braun, two versions of M.scio implants are now available in Australia: the M.scio Flat, designed for continuous intracranial pressure measurement, and the M.scio Dome, which also allows CSF drainage and hypodermic infusion or injection of therapeutic substances. Both are provided with or without a catheter.
Bennett also shared that they are exploring the development of remote monitoring workflows for reviewing ICP data between visits, which would require data to be made accessible first via a secure cloud environment.
"B. Braun anticipates that M.scio will be able to support remote data review in the coming years as these technical and regulatory requirements are met."
FINDINGS
Citing findings from a clinical study published in the Neurosurgery journal of the Congress of Neurological Surgeons, B. Braun notes how M.scio is associated with fewer medical interventions compared with standard reservoirs.
The device was linked to a 61.4% reduction in X-ray scans, 42.8% fewer MRI scans, and 41.3% fewer CT scans, while the need for intracranial pressure monitoring procedures fell by 92.3%. The study also reported 61.9% fewer shunt revisions and a 47.2% decrease in radiation exposure.
The study also revealed that about seven in 10 patients reported clinical benefit following implantation. Longer-term follow-up showed sustained improvement, with roughly three in four patients experiencing symptom relief two years after the procedure.
While there has been no clinical trial in Australia of the device, an early use case there showed how continuous intracranial pressure data from the M.scio implant helped neurosurgeons identify an optimal shunt setting for a 23-year-old hydrocephalus patient in Adelaide after years of repeated shunt revisions and debilitating headaches.
The patient received the implant in August 2024 under the care of neurosurgeon Dr Xenia Doorenbosch at the Women's and Children's Hospital. She had previously struggled with unstable pressure levels despite programmable shunt adjustments. With objective intracranial pressure data from the device guiding treatment, she has since been able to return to work and resume everyday activities, the comms manager from B. Braun shared.
WHY IT MATTERS
Hydrocephalus, a chronic condition characterised by the accumulation and buildup of CSF in the brain, affects about one in 800 newborns in Australia. Normal pressure hydrocephalus (NPH), which presents in seniors and is often mistaken for Alzheimer's or Parkinson's disease, may affect 1%-2% of older adults globally, though its true prevalence in Australia remains undetermined.
The implantable sensor device, M.scio, is positioned as a solution for managing shunt-related complications, CSF disturbances, and intracranial pressure control.
In Australia, M.scio is currently subsidised under the Medicare Benefits Schedule (MBS) for healthcare professionals and is under review for inclusion on the Prescribed List. The sensor-based implant is now being introduced in undisclosed specialist neurosurgical centres in the country. Meanwhile, private health insurance patients in Australia can also consent to using the device.
Additionally, B. Braun is working to introduce in Australia and New Zealand an associated proprietary browser-based software designed to visualise, analyse, and document intracranial pressure data generated by the M.scio implant. Developed initially as a research tool for the device's sensor reservoir system, the software supports systematic evaluation of pressure data that could enable more personalised diagnostic and treatment approaches.
MARKET SNAPSHOT
In the United States, Madison Scientific has attracted investments – having raised $10 million in seed funding last year – to develop and launch a smart system that supports shunt implantation.
Another US company, BrainSpace, received the Food and Drug Administration's 510(k) clearance for its brain fluid management system that allows for CSF drainage at the bedside.
ON THE RECORD
"M.scio lets us review intracranial pressure in real time and in everyday settings, not just a snapshot during a single hospital admission. It shows patterns that reveal what's really happening and how a patient's pressure is related to their symptoms and daily activities. This gives a clearer picture, helps tailor a shunt setting, detect problems sooner, and reduce hospital visits," Dr Xenia Doorenbosch, medical unit head at the Department of Neurosurgery of Women's and Children's Hospital in Adelaide, was quoted as saying in a media release.
