Vittamed Corporation, a neurodiagnostics medical device company based in Boston with R&D operations in Lithuania, today announced it has received CE Mark approval for two novel neuromonitoring devices: the Vittamed 205 for non-invasive intracranial pressure (ICP) measurement and the Vittamed 505 for non-invasive cerebrovascular blood flow 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 and 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 ophthalmic artery as a natural ICP sensor
The Vittamed 505 non-invasively monitors cerebrovascular autoregulation . It allows clinicians to monitor cerebrovascular autoregulation after traumatic brain injury, in stroke, during cardiac surgery, in the critical care unit and in the outpatient clinic.
“Vittamed’s instruments enable clinicians to obtain safer, faster, accurate and cost efficient measurements of absolute intracranial pressure values. We have worked very hard to achieve prospective multicenter clinical validation of these non-invasive diagnostic devices in the US and EU. This platform expands the opportunities for assessing the brain without any material increase in risk. We can also, for the first time, easily monitor conscious individuals and outpatients. This technology opens many new and important clinical and research possibilities for physicians interested in the central nervous system,” said Saulius Rocka, MD, PhD, Principle Investigator and Head of Neurovascular Center at Clinic of Neurology and Neurosurgery ( Vilnius University, Lithuania).
The technology was originally developed at the HealthTelematicsScienceCenter (Kaunas University of Technology, Lithuania) and clinically validated at multiple centers in the EU and USA.
For more information, please visit www.vittamed.com