A clinical research study of a non-invasive intracranial pressure measurement device has been launched by the National Space Biomedical Research Institute (NSBRI) and Vittamed Corporation, the developer of the device. The study will include the monitoring of neurological patients, as a prelude to possible future use with astronauts.
Some astronauts are developing serious visual impairment conditions with associated symptoms suggestive of elevated pressure on the brain, or increased intracranial pressure (ICP). NSBRI, a non-profit entity funded by NASA, has partnered with Vittamed Corporation to independently evaluate their proprietary Vittamed 205 device that can non-invasively measure absolute ICP without the need of patient-specific calibration. "We believe that the Vittamed device holds great promise as a reliable method to non-invasively assess intracranial pressure in astronauts as well as in patients that require monitoring on Earth," said Dr. Dorit Donoviel, NSBRI's Deputy Chief Scientist and Industry Forum Lead.
NSBRI is sponsoring the clinical validation and operational evaluation study, led by Dr. Eric Bershad, a neuro-intensivist and vascular neurologist at Baylor College of Medicine and St. Luke's Medical Center in Houston. "Currently, the only reliable way to monitor the ICP is place a catheter into the brain or cerebrospinal fluid space. Therefore, there is an urgent need to develop non-invasive devices for measuring this important indicator of brain health," said Dr. Bershad.
The Vittamed device was selected by NSBRI after a worldwide search for the most advanced non-invasive ICP technologies. "This is a very important step for Vittamed and we are pleased that NSBRI decided to move forward with a clinical research study of our innovative device," said Vittamed's CEO,Remis Bistras.
The study was initiated in September of 2013 and is due to complete in mid-2014. Vittamed Corporation is providing equipment, training, and expert technical advice. ICP measurements obtained using the Vittamed 205 device are being compared with simultaneous lumbar puncture readings, which are considered the "gold-standard" in patients undergoing evaluation for medical reasons. A total of 40 patients will participate in the study. The Houston team is also evaluating the device for its suitability in assessing the astronauts ICP in the space environment.
The revolutionary technology was initially developed to target patients suffering from traumatic brain injuries, concussions, neurological diseases, hydrocephalus and other complications. "We are thrilled that our technology will help not only clinical patients, but also astronauts, and therefore aid the advancement of space research," said Arminas Ragauskas, Vittamed's Chief Technology Officer, Professor at Kaunas University of Technology, and inventor of the technology.
About Vittamed Corporation
Vittamed is a Boston-based medical device company with research and development operations inLithuania. It has developed a suite of revolutionary clinically proven devices: non-invasive intracranial pressure (ICP) meter and non-invasive real-time Cerebral Autoregulation monitoring device. The patented advanced technology of the Vittamed 205 device uses ultrasound technology to measure absolute ICP levels and does not require patient specific calibration. So far, multiple clinical trials with several hundred traumatic brain injury, neurological and other patients have proven that Vittamed device delivers reliable, clinically acceptable, accurate and precise results as compared to today's standard of care invasive intraventricular and lumbar puncture "gold standard" ICP measurements.
Currently, Vittamed is preparing for regulatory CE mark and 510(k) filings and future commercialization of the devices. For more information, please visit www.vittamed.com.