Revolutionizing Combat Casualty Care
Prytime Medical is spearheading a transformative study under the auspices of the U.S. Army Medical Research and Development Command, aimed at advancing battlefield medicine for trauma cases. This important research analyzes the use of the innovative 2+ hour pREBOA-PRO™ catheter in managing non-compressible torso hemorrhage (NCTH), a leading cause of preventable deaths in military conflicts.
The FORCE Study's Goals
The FIELD Observation of REBOA in Combat Environments (FORCE) study is officially titled A Study of Partial REBOA Use on the Battlefield: Enabling Transport of Combat Casualties with Non-compressible Torso Hemorrhage (NCTH). This research is critical as it directly addresses the urgent need for effective hemorrhage control in challenging combat situations.
Recognizing the unique challenges posed by extreme battlefield conditions, the FORCE study aims to extend the time that medical teams can provide life-saving treatment before evacuation. This is especially vital given the increased evacuation delays observed in recent conflicts.
Critical Developments in Hemorrhage Control
The pREBOA-PRO catheter represents a significant advancement in medical technology. Designed to facilitate True Partial REBOA, this catheter allows medical personnel to stabilize critically injured soldiers for prolonged durations, enhancing their chances of survival during extended transport to hospitals.
Having already been in active use in combat scenarios for over 18 months, this third-generation catheter has received FDA approval and adheres to the stringent standards of the European Union Medical Device Regulation. As a result, it allows for more than 30 minutes of aortic occlusion—an essential breakthrough in trauma care.
Objectives of the FORCE Study
With the pREBOA-PRO catheter at the forefront, the FORCE study seeks to collect valuable observational data to better understand its practical applications in the field. A primary goal is to evaluate the effectiveness of central aortic pressure monitoring and the benefits of extended aortic occlusion on battlefield outcomes.
Ultimately, this study supports the broader efforts by the DOD’s Combat Casualty Research Program (CCCRP) to enhance medical intervention strategies for traumatic injuries, responding effectively to the increasing demands of modern warfare.
The Broader Implication of REBOA Research
Prytime Medical’s initiatives are sustaining a tradition of military medical research. Recently, their efforts have been bolstered by a substantial grant of $6.2 million from the Department of Defense. This funding is aimed at the Partial REBOA Outcomes Multi-Center Prospective (PROMPT) study, which will explore the implications of partial REBOA in treating NCTH patients.
Leading the charge is Dr. Jessica Raley, Principal Investigator for both the FORCE and PROMPT studies. She articulates an unwavering commitment: "No one should bleed to death: that is our company's mission." This encapsulates the essence of Prytime Medical’s vision—ensuring that both civilian and military patients receive timely and effective care.
About Prytime Medical Devices, Inc.
Prytime Medical Devices, Inc. is committed to developing minimally invasive medical solutions for hemorrhage control. Leveraging lessons learned in military situations, the company has pioneered significant advancements with their REBOA technologies. Their flagship products, such as the industry-leading ER-REBOA™ PLUS and the partial REBOA pREBOA-PRO™ catheter, represent state-of-the-art innovations in trauma care.
Understanding the U.S. Army Medical Research and Development Command
The U.S. Army Medical Research and Development Command is crucial in developing battlefield medical solutions. Focused on a variety of biomedical challenges, this organization is dedicated to improving medical responses to combat-related injuries through most advanced research.
Medical Technology Enterprise Consortium (MTEC)
MTEC is a collaborative entity that conducts biomedical research targeting the health and performance of military personnel. Through partnerships and innovative research frameworks, it aims to develop medical solutions that enhance care for those on the front lines.
Frequently Asked Questions
What is the FORCE study?
The FORCE study evaluates the pREBOA-PRO catheter's effectiveness in managing severe hemorrhage in combat situations.
Why is the pREBOA-PRO catheter significant?
This catheter extends the time for providing critical hemorrhage control in trauma patients significantly longer than previous devices.
Who is leading the FORCE study?
Dr. Jessica Raley serves as the Principal Investigator for both the FORCE and PROMPT studies.
What are the overarching goals of the FORCE study?
The study aims to optimize battlefield hemorrhage control and gather vital observational data that can influence future protocols.
What kind of funding supports this research?
The study is funded by the Department of Defense through a $6.2 million grant for comprehensive trauma care research.
