ZOLL Medical Receives FDA Clearance for TBI Dashboard on Its Propaq M Monitor and Propaq MD Monitor/Defibrillator
ZOLL® Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, today announced that it has received FDA 510(k) clearance to release the TBI Dashboard™ feature on its Propaq® M monitor and Propaq MD monitor/defibrillator. 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 U.S. 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 U.S. 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.
ZOLL and the Military
For more than 25 years, ZOLL has been a trusted partner delivering acute critical care technologies to the military. ZOLL products are extensively utilized throughout the entire military healthcare system in support of the warfighter and casualty care treatment within all roles of the operational En-Route Care System, and in disaster and humanitarian responses. ZOLL's leading resuscitation and critical care technologies are used in all roles of operational medical care on the battlefield, in aeromedical evacuation and transport, in field hospitals, and in garrison for definitive care.
About ZOLL Medical Corporation
ZOLL Medical Corporation, an Asahi Kasei company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and cardiac monitoring, circulation enhancement and CPR feedback, supersaturated oxygen therapy, data management, ventilation, and therapeutic temperature management, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, as well as lay rescuers, improve patient outcomes in critical cardiopulmonary conditions. For more information, visit www.zoll.com.
About Asahi Kasei
The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 40,000 employees around the world, the company contributes to sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. For more information, visit www.asahi-kasei.com.
1Pazdan R, et al. Traumatic Brain Injury in the Military. Fundamentals of Military Medicine. Borden Institute-Office of the Surgeon General U.S. Army MedCoE. 2019, Chapter 38.
Copyright © 2021 ZOLL Medical Corporation. TBI Dashboard, X Series, and ZOLL are trademarks or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries. Asahi Kasei is a registered trademark of Asahi Kasei Corporation. All other trademarks are the property of their respective owners. Propaq is a registered trademark of Welch Allyn.