Zoll Medical Corp has received FDA 510(k) clearance to release the TBI Dashboard feature on its Propaq M monitor and Propaq MD monitor/defibrillator in the United States. TBI Dashboard provides clinical decision support for managing patients with TBI (traumatic brain injury) and was previously available on Propaq devices in international markets. With the FDA clearance announced today, Zoll can now bring this capability to the US market.
TBI remains a significant issue in modern warfare, with frequent diagnoses in both combat and training environments.1 TBI patients present a unique set of challenges. Close monitoring of vital signs and early treatment are both critical to minimize secondary injuries, which are common with severe TBI patients. Patients often do not die as a consequence of the primary injury but rather due to secondary brain injury that occurs after the initial impact.2
TBI Dashboard displays numeric and graphical trend data on what the EPIC study refers to as the “three H-bombs”: hypotension, hypoxia, and hyperventilation. Providing continuously updated vital-signs data at a glance allows medical personnel to make treatment decisions before a patient’s status becomes critical, as recommended by the TCCC guidelines3 and demonstrated by the EPIC study.4 In addition to monitoring key vital signs, TBI Dashboard also includes a breath-by-breath countdown timer to help care providers maintain proper ventilation rates and prevent hyperventilation.
“Zoll is focused on providing products that improve patient outcomes. TBI Dashboard offers clinical decision support capabilities that help medics improve outcomes for injured warfighters. Zoll is proud to offer meaningful improvements to our Propaq series monitor/defibrillator and is honored to be a trusted partner delivering acute critical care technologies to the US military,” said Elijah White, President of Zoll Resuscitation.
From the point of injury throughout the continuum of en-route care, Zoll’s Propaq M and Propaq MD monitor/defibrillators, now with TBI Dashboard capabilities, support rapid treatment and effective management of TBI patients. TBI Dashboard is also available and approved for use on Zoll’s X Series Advanced monitor/defibrillator.