Military-civilian partnership in device innovation: development, commercialization and application of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA).

Noncompressible torso hemorrhage (NCTH) and shock is a leading cause of trauma-related mortality and evidence suggests that survival from this injury pattern has not improved in decades. As such, innovating new approaches and devices, including technologies which can be used by providers within a short of time after severe injury, is a priority for the military. Guided by wartime observations, and through partnerships with civilian academia and private investment, the military has led an effort to define resuscitative endovascular balloon occlusion of the aorta (REBOA) and assess its potential to address this problem. The result of this effort is development and commercialization of new REBOA-specific device referred to as the ER-REBOA(TM) catheter. This device has been approved by regulatory agencies in the US and abroad and is now being used in civilian trauma centers and by military teams in the deployed setting. Despite excellent device performance and an empiric benefit of its use, there remains skepticism over this disruptive change in practice and an expressed need for more robust data to prove its effectiveness. This commentary reviews of the origins of the REBOA effort and the ER-REBOA(TM) catheter and outlines key factors influencing its development, commercialization and implementation. This essay also outlines post-market surveillance mechanisms which are tracking use of the ER-REBOA(TM) catheter as well as plans for prospective, multi-center studies of REBOA in the U.S. and U.K. With this reset on the origins, rationale and progress of REBOA, it's hoped that military-civilian partnerships in this endeavor can be strengthened and that debate of this topic can be evidence-based, balanced and productive. (C) 2017 Lippincott Williams & Wilkins, Inc.

from Emergency Medicine via xlomafota13 on Inoreader http://pdfs.journals.lww.com/jtrauma/9000/00000/Military_civilian_partnership_in_device.98971.pdf