BOSTON — Vittamed Corporation, a neurodiagnostics medical device company based in Boston with R&D in Lithuania, today announced it has received the CE Mark of approval for two novel neuromonitoring devices: the Vittamed 205 for non-invasive intracranial pressure (ICP) measurement and the Vittamed 505 for non-invasive Cerebrovascular autoregulation monitoring.
"CE approval for both devices is not only an important milestone for our company as we move toward commercialization but also an important advance in patient care," stated Dr. Remis Bistras, the CEO of Vittamed. "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."
Both devices are ultrasound based. The Vittamed 205 offers non-invasive ICP measurement for conditions such as traumatic brain injury, concussion, hydrocephalus, stroke, brain tumors, and other neurological diseases. The ICP meter is clinically validated in prospective clinical trials, provides accurate and precise measurements and does not require an individual patient specific calibration. The device uses safe Doppler ultrasound and measures absolute ICP value in mmHg using the ophthalmic artery as a natural ICP sensor.
The Vittamed 505 non-invasively monitors cerebrovascular autoregulation. It allows clinicians to monitor cerebrovascular autoregulational and evaluate cerebral blood flow after traumatic brain injury, in stroke, during cardiac surgery, in the critical care unit and in the outpatient clinic.
"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," said Saulius Rocka, MD, PhD, Principle Investigator and Head of Neurovascular Center at Neurology and Neurosurgery Clinic at Vilnius University, Lithuania
The technology was originally developed at the Health Telematics Science Center at Kaunas University of Technology, Lithuania and is clinically validated in prospective multicenter clinical trials in the EU and USA.
Press release via Vittamed.