Endovascular Variable Aortic Control Device

In military trauma, recent analyses of fatalities sustained in Operation Iraqi Freedom and Operation Enduring Freedom identified abdominal hemorrhage as the leading cause of preventable death on the battlefield. The currently available medical solution is an endovascular technique called resuscitative endovascular balloon occlusion of the aorta (REBOA), which is used to occlude the aorta with a balloon catheter inserted into a large artery in the groin. Use of this technique allows downstream blood flow to be impeded, which controls hemorrhage while augmenting perfusion to the heart, lungs, and brain. However, because the REBOA technique restricts blood supply to downstream tissues, this also causes a shortage of oxygen and glucose needed to keep tissue alive. The result is that despite arriving to definitive care alive, there is little benefit to the patient if the tissue blocked by the occlusive balloon has become irreversibly damaged. Therefore, the development of technologies to control hemorrhage and resuscitate the injured warfighter, while minimizing distal ischemia (tissue damage) is a high priority to the DoD.

The MHRF is developing a potential solution to avoid both non-compressible truncal hemorrhage on the battlefield and the resulting distal ischemia from the currently available life-saving technique. Through advanced development, our solution provides the ability to titrate the degree of aortic occlusion in response to the patient’s physiology, so that blood flow is only minimally restricted.

The MHRF is partnering with the 60th Clinical Investigation Program (CIP) at Travis AFB to design and develop new endovascular variable aortic control (EVAC) devices to attenuate aortic blood flow. To date, the 60th CIP has successfully completed 2 proof-of-concept studies to establish the clinical utility of variable aortic control of hemorrhagic shock. Variable aortic control results in less tissue damage during transport off the battlefield and may provide comparable control of non-compressible hemorrhage.

Any patient undergoing a surgery with significant risk of hemorrhage will benefit from having a low-profile EVAC deployed that will allow for precise regulation of distal aortic flow, while effectively augmenting vital perfusion to organs proximal to the EVAC.