ZOLL Medical Obtains FDA Clearance for TBI Dashboard on its Propaq M Monitor and Propaq MD Monitor / Defibrillator

CHELMSFORD, Mass .– (COMMERCIAL THREAD) – ZOLL® Medical Corporation, an Asahi Kasei company that manufactures medical devices and associated software solutions, today announced that it has received 510 (k) clearance from the FDA to launch the TBI Dashboard ™ feature on its Propaq® M and Propaq MD / defibrillator monitors. TBI Dashboard provides clinical decision support for the management of patients with TBI (head injury) and was previously available on Propaq devices in international markets. With FDA clearance announced today, ZOLL can now bring this capability to the US market.

TBI remains a significant problem in modern warfare, with frequent diagnoses in combat and training environments.1 TBI patients present a unique set of challenges. Close monitoring of vital signs and early treatment are both essential to minimize secondary injuries, common in patients with severe TBI. Often, patients do not die from the primary injury, but rather from a secondary brain injury that occurs after the initial impact.2

The TBI dashboard displays digital and graphical trend data on what the EPIC study calls the “Three H bombs”: hypotension, hypoxia and hyperventilation. Providing continuously updated vital signs data at a glance allows medical staff to make treatment decisions before a patient’s condition becomes critical, as recommended by TCCC guidelines3 and demonstrated by the EPIC study.4 In addition to monitoring key vital signs, TBI Dashboard also includes a breath-to-breath countdown to help healthcare providers maintain proper ventilation rates and prevent hyperventilation.

“ZOLL is focused on providing products that improve patient outcomes. TBI Dashboard provides clinical decision support capabilities that help physicians improve outcomes for injured combatants. ZOLL is proud to offer significant improvements to our Propaq series monitor / defibrillator and is honored to be a trusted partner providing acute critical care technologies to the US military, ”said Elijah White, President of ZOLL Resuscitation.

From the point of injury throughout the continuum of care en route, ZOLL’s Propaq M and Propaq MD monitors / defibrillators, now featuring TBI Dashboard capabilities, support rapid treatment and efficient management of TBI patients. The TBI instrument panel is also available and approved for use on the ZOLL X series® Advanced monitor / defibrillator.

ZOLL and the army

For over 25 years, ZOLL has been a trusted partner providing acute critical care technology to the military. ZOLL products are widely used throughout the military health system in support of combatant and casualty care in all roles of the operational en route health care system, and in disaster and humanitarian response. . ZOLL’s leading resuscitation and critical care technologies are used in all operational medical care roles on the battlefield, in evacuations and aero-medical transports, in field hospitals and in garrison for definitive care.

For more information, visit www.zoll.com and www.zoll.com/medical-markets/military/.

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 efficiency. With products for defibrillation and cardiac monitoring, improved circulation and CPR feedback, supersaturated oxygen therapy, data management, ventilation and therapeutic temperature management, ZOLL provides a A comprehensive set of technologies that help clinicians, emergency and fire service professionals, as well as lay rescuers, improve outcomes for patients with critical cardiopulmonary conditions. For more information, visit www.zoll.com.

About Asahi Kasei

The Asahi Kasei Group contributes to the lives and the lives of people around the world. Since its founding in 1922 with ammonia and cellulose fiber businesses, Asahi Kasei has grown steadily through the proactive transformation of its business portfolio to meet the ever-changing needs of every age. With more than 40,000 employees worldwide, the company contributes to a sustainable society by providing solutions to global challenges through its three business segments of materials, homes and healthcare. Its healthcare business includes devices and systems for acute intensive care, dialysis, therapeutic apheresis, transfusion, and the manufacturing of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. For more information, visit www.asahi-kasei.com.

1Pazdan R, et al. Head trauma in the military. Foundations of military medicine. Borden Institute-Office of the Surgeon General US Army MedCoE. 2019, chapter 38.

2Centers for Disease Control and Prevention (CDC), Traumatic Brain Injury (TBI): Incidence and Distribution, 2004.

3Joint Trauma System / Tactical Combat Casualty Care Committee, TCC Guidelines August 1, 2019.

4Spaite DW et al. JAMA surgery. July 1, 2019; 154 (7): e191152.

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.

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