European Regulators Approve Two Brain Monitors From Vittamed

Vittamed Corporation has received CE Mark approval for a pair of devices that use ultrasound technology to monitor the brain in a noninvasive manner. The Vittamed 205 system is used to monitor intracranial pressure, while the Vittamed 505 is designed to measure cerebrovascular autoregulation.

“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,” said Dr. Remis Bistras, CEO. “Invasive options for intracranial pressure measurement and for cerebral perfusion monitoring have historically been limited by risk, inconvenience, and high costs. Our monitors add no material risk. They are totally non-invasive and may be deployed routinely whenever and wherever indicated, including the outpatient setting.”

The Vittamed 205 intracranial pressure monitor works by applying pressure to the tissue surrounding the eye using a special pressure cuff. A Doppler ultrasound transducer placed over the eye measures blood flow through the intracranial and extracranial parts of the ophthalmic artery. The blood flow through the extracranial segment changes as the pressure is applied to the eye, while the intracranial segment responds to the intracranial pressure. Applying pressure to the eye until the blood flow matches in the two segments of the ophthalmic artery results in equal pressure in both parts and a readout is produced by the system. This technique does not require calibration for each patient and the company claims there’s little to no discomfort during the procedure.

The Vittamed 505 is a non-invasive monitor of cerebrovascular autoregulation, the method by which the arteries in the brain narrow and widen in response to breathing and blood pressure. The device works by sending ultrasound beams through the head and detecting how the signal is attenuated as it exits on the opposite end. It offers continuous monitoring of the brain and can be performed as needed, since this is a non-invasive procedure. The company touts that in a study of 13 patients the device has provided “no statistically significant difference” compared to data gathered from invasive ICP and arterial probes.

“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, M.D., Ph.D, principle investigator and head of Neurovascular Center  at Neurology and Neurosurgery Clinic at Vilnius University in 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 European Union and United States.

Vittamed is a neurodiagnostics medical device firm with offices in Kaunas, Lithuania, and Boston, Mass.