SBIR-STTR Award

Non-compressible torso hemorrhage (NCTH) is a leading cause of death when immediate access to surgical intervention is not feasible. Resuscitative endovascular balloon occlusion of the aorta (REBOA), is an emerging and promising lifesaving procedure that involves placement and inflation of a small balloon catheter inside the aorta to control torso bleeding and to maintain blood pressure. However, irreversible ischemic organ damage below the balloon is frequent. As a result, partial-REBOA approaches that titrate blood flow past the balloon have been shown in limited swine and human studies to extend the time for balloon inflation from less than one hour to up to two hours. We propose a smart-REBOA catheter that titrates blood flow past the balloon to reduce irreversible damage to downstream organs while monitoring and maintaining hemodynamic status. Our smart-REBOA catheter is designed to work seamlessly with our handheld Automated Vascular Access Device for semi-automated REBOA catheter placement. In Phase I, we will develop a preliminary design for a prototype system and demonstrate overall feasibility. In Phase II, we will develop a prototype system and will evaluate its effectiveness. In Phase III, we will validate the technology through clinical trials and will use that data to obtain FDA clearance.

Non-compressible torso hemorrhage (NCTH) is a leading cause of death when immediate access to a surgeon is not feasible. Resuscitative endovascular balloon occlusion of the aorta (REBOA), is an emerging and promising lifesaving procedure that involves placement and inflation of a small balloon catheter inside the aorta to control torso bleeding and to maintain blood pressure. However, irreversible organ damage below the balloon is unavoidable, and as a result, partial-REBOA approaches to enable controlled bleeding past the balloon are thought to be able to extend the time window for definitive treatment from less than one hour to up to two hours. We propose a smart-REBOA catheter that autonomously performs controlled bleeding to reduce irreversible damage to downstream organs while monitoring and maintaining hemodynamic status to preserve life. Importantly, our smart-REBOA catheter is designed to work seamlessly with our handheld Automated Vascular Access Device (AVAD) for semi-automated J-wire/catheter placement. In Phase I, we developed a preliminary design for a prototype system and demonstrated overall feasibility. In Phase II, we plan to develop a prototype system and evaluate its effectiveness with phantoms and swine experiments. In Phase III, we will validate the technology through clinical trials and will use that data to obtain FDA clearance.