Improving REBOA in Five (Not So) Easy Steps
It’s a scene familiar to trauma physicians and first responders alike. A patient is crashing from severe bleeding. Blood pressure is out of control, and you struggle to keep the patient stable. In that moment, what tools do you have at your disposal to save that life?
When you step back, it’s apparent that the methods we have for treating this kind of trauma are insufficient. They are still rudimentary. One of the newest interventions on the scene is also one of the riskiest, so much so that it’s still considered experimental in many respects: the resuscitative endovascular balloon occlusion of the aorta (REBOA) procedure.
While REBOA has piqued the interest of critical care providers and first responders across the globe, the procedure has some serious shortcomings. These limitations are not an impassable barrier–they are an opportunity to innovate. Certus Critical Care, an early stage medical device company, has tackled the problems with the REBOA procedure, and its core product will advance the treatment of individuals suffering from hemorrhage and other traumatic conditions into the 21st Century.
“Most of these obstacles exist because we have not had the scientific basis or the physical devices to address them–until now. ”
Shortcomings of REBOA
The basic premise of REBOA is the use of a balloon catheter to completely block the aorta to help control bleeding as medical professionals fix the underlying trauma.
While REBOA has been integrated into some clinical and prehospital settings, there are some significant (and well-documented) limitations to the procedure:
Blocking the aorta restricts blood flow to lower extremities, which can cause tissue damage and death.
Because of the risks to lower extremities, the time span the balloon can be used is extremely limited.
Deflating the balloon can cause additional damage, such as vascular complications and re-arrest in patients being treated for cardiac arrest.
Current REBOA technologies are susceptible to interference and inaccurate blood pressure readings, which can be dangerous when used as a guide for clinical decisions.
Most of these obstacles exist because we have not had the scientific basis or the physical devices to address them–until now.
Certus has researched and developed a single-use aortic balloon occlusion catheter that incorporates patented sensor technology and data analytics to provide precise and variable control of blood pressure and flow on a minute-by-minute basis. Called the Endovascular Aortic Control (EVAC) system, it improves on the REBOA procedure to offer a more effective, safer option for treating hemorrhage and cardiac arrest.
“Without a dynamic approach to care, REBOA can become extremely unsafe.”
Based on extensive, peer-reviewed research conducted by our founders, EVAC uses automation to partially block the aorta to control bleeding while decreasing the negative side effects associated with REBOA. Here are five ways that the EVAC technology revolutionizes the REBOA procedure to make it safer and more effective in treating critically ill and injured patients.
1. Dynamic Control
In emergency situations, a patient’s condition is continually changing and requires constant adjustment to maintain stability. Nowhere is this more evident than in maintaining blood pressure, which fluctuates frequently. Current REBOA technologies don’t have the capacity to adjust with changes in blood pressure. In hemorrhage treatment, simply setting a balloon catheter and leaving it ignores one of the most crucial elements of critical care. Without a dynamic approach to care, REBOA can become extremely unsafe.
Our EVAC technology is more than a static balloon catheter; its proprietary algorithms monitor a patient’s condition on a second-by-second basis and respond by either increasing or decreasing the occlusion of the aorta to maintain blood pressure stability. The technology continually assesses a patient’s condition and adjusts inflation of the balance with a frequency that caregivers do not have the capacity to provide.
2. Precision Control
Not only does a patient’s condition fluctuate constantly, but it can also be influenced by the smallest of changes. Foundational research done by Certus indicates that even incremental changes in the inflation of a balloon catheter can significantly influence blood pressure. Current REBOA technologies lack the sophistication and automation to make the small changes in hemodynamics required to keep blood pressure stable.
The EVAC system, however, can make changes to the inflation of the balloon on a magnitude not possible with human administration. The automation of the device can control a patient’s blood pressure in the minutest of ways and provide a level of stability never possible before. This precision control can make a significant difference in patients’ outcomes.
3. High-fidelity Data
High-fidelity Sensors
One of the greatest limitations of current catheters is that they do not produce reliable data, particularly when measuring downstream blood pressure. The sensors that REBOA technologies use are easy to disrupt–even slight positioning changes relative to the patient can significantly affect blood pressure readings. The results of these erroneous readings can be disastrous for patients if used to control balloon inflation or deflation.
The EVAC uses solid state sensors that measure absolute blood pressure both above and below the balloon. Its proprietary sensors are not susceptible to the same mechanical disruptions as other catheters and produce high-fidelity data that can be relied upon to make adjustments and guide decision-making on the part of medical professionals.
4. Fewer Side Effects
The very thing that makes REBOA useful–full occlusion (or complete blockage) of the aorta–quickly becomes a liability by causing tissue damage or death in the lower extremities. With the current procedure, the balloon catheter must be set to fully occlude the aorta from the very beginning, and there is little control over how it deflates–and how that affects the patient. There’s not much room for adjustment or flexibility.
EVAC’s responsive technology can begin with partial occlusion and be inflated and deflated on a continuous basis to allow enough blood flow to avoid tissue damage in lower extremities while still controlling the hemorrhage. By adapting continually to the needs of the individual patient and gradually deflating, EVAC can prevent sudden swings in blood pressure and maintain blood flow, rather than operating like the on-off switch that limits current technologies.
5. Increased Treatment Time
Because of the negative side effects of the REBOA procedure, medical professionals have a limited amount of time that they can use the intervention. Complete occlusion can be used for mere minutes before ischemia kicks in and irreversible organ damage occurs
The ability of EVAC to regulate blood pressure using partial occlusion through its proprietary algorithms prolongs the time that clinicians and first responders have to work. By incrementally changing blood pressure within a patient, EVAC staves off ischemia and subsequent tissue damage, allowing more time for medical professionals to address a patient’s trauma. In fact, studies have shown EVAC may triple the time providers have to intervene. With more time to work, medical professionals can help patients achieve better outcomes.
Founder, Tim Williams, MD
“With more precision control and continuous care, EVAC gives medical providers the input and time they need to care for patients. ”
Building a Better Foundation
The EVAC system creates a safer, more effective method for treating severe hemorrhage and cardiac arrest than the REBOA procedure. With more precision control and continuous care, EVAC gives medical providers the input and time they need to care for patients.
Every innovation of our EVAC technology is based on an extensive body of research. At Certus, we have conducted over 300 studies to develop the bedrock for our pipeline of technologies, all motivated by the goal of revolutionizing critical care and saving lives. Explore our research publications to learn more about the science behind EVAC.
EVAC is awaiting FDA premarket clearance. With a fresh infusion of funding, we believe indications for our technology will also extend to stroke care, where the regulation of blood pressure is important for improving patient outcomes. The EVAC system is also the basis for other essential technologies in the Certus pipeline.
All our technologies are based on the foundations of precision sensing and intervention and continuous care–made possible through modern computation and device manufacturing capabilities. Through them, we hope to improve the outcomes for patients suffering from critical injuries and illnesses.