A coin-sized implantable sensor designed to monitor pressure inside the brain has been approved for use in Australia, offering clinicians a new way to manage hydrocephalus and potentially reducing the need for repeated scans and surgical interventions.
The device, commercialised by medical technology company B. Braun and known as M.scio, is the first long-term implantable telemetric intracranial pressure monitoring sensor approved in Australia for patients with hydrocephalus, a neurological condition in which cerebrospinal fluid accumulates in the brain and increases pressure on brain tissue. The condition can affect people across the lifespan, from newborns through to older adults.
The implant is designed to sit along the shunt tubing at the burr hole site in the skull. A silicone membrane within the device responds to changes in cerebrospinal fluid pressure, which are detected by a measuring cell and transmitted wirelessly to a handheld receiver so clinicians can review intracranial pressure readings in real time.
Hydrocephalus remains a significant clinical challenge. In Australia, around one in 800 newborns is affected by the condition, while normal pressure hydrocephalus is most commonly seen in people in their sixties and seventies. Because its symptoms can resemble Alzheimer’s disease or Parkinson’s disease, it is frequently overlooked or misdiagnosed.
Dr Raj Reddy, Adjunct Associate Professor and neurosurgeon at Prince of Wales Private Hospital, said awareness of the condition remains crucial because effective treatment is possible when it is identified correctly.
“While Normal Pressure Hydrocephalus (NPH) is one of the few truly treatable causes of dementia like symptoms, the challenge lies in its diagnosis,” he said. “For this reason, it's essential for everyone involved from treating physicians to family members and patients to consider that the triad of gait disturbance, cognitive decline and urinary incontinence could point directly to NPH, opening the door for effective, life changing treatment.”
The approval of M.scio could help clinicians gain a more detailed picture of intracranial pressure changes over time. Unlike traditional monitoring that provides only a snapshot during hospital assessment, the implant allows pressure trends to be reviewed repeatedly and in everyday circumstances.
Dr Xenia Doorenbosch, Medical Unit Head in the Department of Neurosurgery at the Women’s and Children’s Hospital in Adelaide, said the ability to monitor pressure patterns outside the hospital environment could change how clinicians manage the condition.
“M.scio lets us review intracranial pressure in real time and in everyday settings not just a snapshot during a single hospital admission,” she said. “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. Most importantly, it offers patients and families greater certainty and reassurance.”
Clinical data suggest the technology may also reduce the need for some diagnostic procedures and surgical revisions. Studies have reported significant reductions in imaging, including 61.4 per cent fewer X-rays, 42.8 per cent fewer MRI scans and 41.3 per cent fewer CT scans compared with standard reservoirs. Shunt revision procedures were reduced by 61.9 per cent.
Patient outcomes have also shown promising results. Around 70 per cent of patients receiving the implant reported clinical benefits, with longer-term follow-up indicating that 75 per cent experienced symptom relief two years after implantation.
The technology has already been used for more than a decade in the United Kingdom. Miss Claudia L Craven, Paediatric Neurosurgery Consultant at Cambridge University Hospitals, said the device has become a routine tool in managing hydrocephalus surgery there.
“M.scio has become an essential tool in UK hydrocephalus surgery, providing accurate, real time shunt diagnostics that reduce unnecessary anaesthetics, imaging and hospital admissions, particularly in children,” she said. “Data from centres including NHNN Queen Square and Royal Hallamshire Hospital show it is both clinically effective and cost-efficient, reducing repeat investigations and shunt revisions.”
Two variants of the implant are now available in Australia. One is designed for measuring intracranial pressure in patients with hydrocephalus, while the second also enables therapeutic injections or cerebrospinal fluid drainage when required.
The device is currently being introduced in specialist neurosurgical centres and is subsidised under the Medicare Benefits Schedule, although it is not yet listed on the Prescribed List. Surgeons treating privately insured patients may seek prior approval based on clinical need.