FDA Grants Clearance for Fully Implantable Wireless Intracranial Pressure Sensor
The AURA intracranial pressure (ICP) monitoring system (Branchpoint Technologies, Irvine, CA) has been granted clearance by the Food and Drug Administration (FDA). This first of kind system is fully implantable and wireless, enabling continuous telemetric monitoring of parenchymal ICP, including continuous ICP waveforms. The system enables truly mobile ICP monitoring in brain-injured patients in a completely wireless system for both power and transmission of patient data directly to a bedside monitor. In addition to providing a more flexible option for patients, the system also eliminates the need for additional capital equipment investments.
"The AURA ICP monitoring system is a ground breaking and long-sought advancement that enables ICP monitoring without the need for a tethered connection between the patient's brain and the bedside monitor," said Dr. Michael Muhonen, Director of Neurosurgery and Medical Director of the Neuroscience Institute at Children's Hospital of Orange County (CHOC). "With traditional ICP monitoring systems, patient mobility within the hospital is cumbersome and product dislodgement and malfunction is common. AURA™ solves these problems, facilitates better ICP vigilance throughout the hospital and will benefit our patients immediately. Longer term, I am equally excited by the potential of the AURA™ platform in combination with a shunt for better hydrocephalus management."