Prytime Medical Devices said that the US Army Medical Research and Development Command (USAMRDC) is conducting a new study to evaluate the effectiveness of the pREBOA-PRO catheter.
The 2+ hour catheter will be assessed for treating casualties in difficult combat environments.
The study, titled Field Observation of REBOA in Combat Environments (FORCE) will focus on managing severe haemorrhage on the battlefield.
The FORCE study will use the pREBOA-PRO catheter to extend partial aortic occlusion time. This extension aims to enhance triage, treatment, and transport for critically injured patients.
The study started in September 2024. It is funded by the US Department of Defense (DOD) Combat Casualty Research Program (CCCRP) through an MTEC solicitation MTEC-24-01-MPAI.
The pREBOA-PRO catheter is a third-generation device approved by the US Food and Drug Administration (FDA) and the European Union (EU) Medical Device Regulation (EU MDR).
This catheter has been used in combat in Ukraine for over 18 months. It extends the safe use of resuscitative endovascular balloon occlusion of the aorta (REBOA) beyond 30 minutes.
According to Prytime Medical Devices, the catherer allows forward medical teams to haemodynamically stabilise critically injured soldiers outside hospitals. It also enhances their chances of survival during extended transport.
The pREBOA-PRO catheter’s patented technology offers over two hours of haemorrhage control and resuscitation support through partial aortic occlusion of the aorta.
The FORCE study will build on 18 months of successful combat use of the pREBOA-PRO catheter.
It aims to formally collect observational data on the effectiveness of this new 2+ hour partial REBOA device in extremely remote and forward combat environments.
Key objectives include assessing the utility of central aortic pressure monitoring and the impact of extended aortic occlusion on the battlefield.
FORCE study principal investigator Jessica Raley said: “We’re passionate about finding new ways for civilian and combat wounded patients to reach definitive care, and we’re grateful for the opportunity to document the latest REBOA combat casualty management strategies and share them with the world.”
REBOA has a history of military research and funding. Recently, the USAMRDC awarded Prytime Medical Devices $6.2m through the Medical Technology Enterprise Consortium.
This funding will support a study focused on non-compressible torso haemorrhage (NCTH) patients treated with the pREBOA-PRO catheter.
This initiative, known as the Partial REBOA Outcomes Multi-Centre Prospective (PROMPT) study, is set to be completed by 30 November 2025.
