US-based neurodiagnostics firm Vittamed has secured CE Mark approval for its Vittamed 205 for non-invasive intracranial pressure (ICP) measurement and Vittamed 505 for non-invasive cerebrovascular autoregulation monitoring devices.
The company said that both Vittamed 205 and Vittamed 505 are ultrasound-based devices.
The Vittamed 205 provides non-invasive ICP measurement for conditions such as traumatic brain injury, concussion, hydrocephalus, stroke, brain tumours, and other neurological diseases.
By using Doppler ultrasound and the ophthalmic artery as a natural ICP sensor, the Vittamed 205 measures absolute ICP value in mmHg.
Clinically validated in prospective clinical trials, the ICP meter is claimed to offer accurate and precise measurements and does not require an individual patient specific calibration.
Vittamed CEO Remis Bistras said: "CE approval for both devices is not only an important milestone for our company as we move toward commercialisation but also an important advance in patient care.
"Invasive options for intracranial pressure measurement and for cerebral perfusion monitoring have historically been limited by risk, inconvenience, and high costs.
"Our monitors, in contrast, add no material risk. They are totally non-invasive and may be deployed routinely whenever and wherever indicated, including the outpatient setting."
The Vittamed 505 enables clinicians to non-invasively monitor cerebrovascular autoregulational, as well as assess cerebral blood flow after traumatic brain injury, in stroke, during cardiac surgery, in the critical care unit and in the outpatient clinic.
Vilnius University Neurology and Neurosurgery Clinic Neurovascular Center head Saulius Rocka said: "We have been very encouraged with the results of non-invasive diagnostic devices.
"This platform gives us, neurosurgeons, the possibility to understand what is happening in the brain without invasion and any increase in risk for patient.
"We can also, for the first time, easily monitor conscious individuals and outpatients.
"Vittamed’s instruments enable clinicians to obtain safer, faster, and accurate measurements of absolute intracranial pressure values."