New Device: A possible game-changer on the battlefield and in medicine worldwide

ER-REBOA catheter buying time and saving lives

By Sarah Marshall

Born out of necessity on the battlefield, a new device is buying vital time for critically wounded patients, both in combat and in emergency care environments worldwide -- vital time that could help save a life.

The device is known as ER-REBOA, or a resuscitative endovascular balloon occlusion of the aorta. It was developed by Air Force Col. (Dr.) Todd Rasmussen, associate dean for Clinical Research at the Uniformed Services University (USU), and Dr. Jonathan Eliason, associate professor of Vascular Surgery at the University of Michigan. From 2004-2007, the two surgeons were assigned together at Lackland Air Force Base in San Antonio and served tours at the military’s level III surgical hospital in Balad, Iraq. During their deployments, they both frequently saw combat trauma patients with critical injuries to the abdomen and pelvis – areas where it can be nearly impossible to control hemorrhaging to save a patient’s life. While tourniquets helped prevent service members from bleeding to death from wounds to their arms and legs, nothing existed for this part of the body. There was an urgent need for a solution, Rasmussen said, and he was sure there had to be a better way to help these patients.

He and Eliason put their heads together and came up with an approach that wasn’t particularly new, Rasmussen explained. Their idea was similar to the concept of a common endovascular procedure, cardiac catheterization, which is used to help treat a blocked artery or an aneurysm by threading a long, thin tube -- a catheter -- through a small incision in the groin, and up through a vein or artery.

The two surgeons contrived a similar catheter with a small balloon at the end that is inserted through a two- to three-millimeter incision near the groin, guided up through the femoral artery, into the aorta. The balloon is then positioned to the desired level of the aorta and inflated with saline, blocking the aorta, and cutting off circulation to the legs and pelvis, while still allowing blood to flow normally to the brain, heart, lungs and other vital organs. This creates what could be described as an “internal tourniquet,” Rasmussen said. This helps temporarily stop severe blood loss in the pelvic and abdomen area, which can allow a patient to stabilize as they begin to receive blood products and are transported to a higher level of trauma care – buying them critical time that they might not have had without the device.

“We had the vision for it, and we knew the elements of this approach worked very effectively for certain vascular disease conditions such as coronary artery disease and ruptured aortic aneurysms,” Rasmussen said.

In the following years, the surgeons were able to pair up with an entrepreneurial company that helped them create a more refined prototype. With the prototype, they conducted further research, producing data to demonstrate the device’s effectiveness, which led to it ultimately being patented jointly by the Department of Defense and the University of Michigan. It received FDA approval in November 2015 and was given the name ER-REBOA; the “ER” stands for “Eliason” and “Rasmussen.” It’s become commercialized and, for the past year has not only been used in combat, but also in emergency and critical care environments worldwide. Bringing this to fruition has been a long but exciting journey but, Rasmussen said, their work is not yet complete.

Air Force Col. (Dr.) Todd Rasmussen, associate dean for Clinical Research at USU, was deployed five times to Iraq and Afghanistan over the last 13 years.  His combat medicine experience led him to help develop the ER-REBOA, a device that’s now helping to save lives both in combat and in emergency care environments worldwide.  (Image credit: courtesy of Col. (Dr.) Todd Rasmussen)

The next steps are to continue researching the device’s effectiveness, explained Eliason, who retired from the military in 2007 and has since worked as a vascular surgeon at the University of Michigan. Today, they’re conducting clinical studies to help determine which patients the device should be used on, which practitioners are best suited to administer it, when, and for how long. Like a regular tourniquet, he said, it cannot be left on permanently as that can cause damage, so it’s important to determine these factors.

Down the road, Rasmussen said he sees the device making an impact not only for trauma patients who are hemorrhaging, but also in post-partum hemorrhaging, during complicated pregnancies, to potentially help save a mother’s life during delivery. The device could also help save lives from a heart attack or cardiac arrest, possibly if used in conjunction with CPR, he added.

“We’re very excited about the potential of this technology,” Rasmussen said.

He credits the efforts of the entire team that worked to help make this possible, including the Department of Defense, the University of Michigan, and the entrepreneurial company.

He went on to say that the project has been rewarding in a different way.

“It allows us to develop a technology that can potentially help hundreds of patients -- and that’s new to me,” he said. And as he’s heard from doctors around the world who are interested in using this device, he added, “That’s very gratifying on a different level.” Rasmussen said it’s rewarding to be part of something that may give providers a tool they can use effectively. Trying to save a patient who is losing significant amounts of blood, while looking for ways to control the blood loss is really hard, he said. “I know that personally.”

Air Force Maj. (Dr.) Justin Manley also knows firsthand what it’s like to be in such a scenario. In July 2016, while deployed as a general surgeon in support of operations in the Middle East, he faced a similar situation receiving a patient in near cardiovascular collapse, which is almost always fatal. He quickly made the decision to use the device, becoming the first surgeon to use it while in a combat setting. As a result of his actions, the patient survived.

“We were very excited to have the opportunity to be able to use the device because we understood its potential,” said Manley, who is assigned to a Special Operations Surgical Team (SOST) in the 720th Operations Support Squadron at Hurlburt Field, Florida. SOSTs deploy far forward into hostile or austere areas to perform life-saving surgeries with little to no support from medical facilities or systems.

During that 2016 deployment, Manley and his team used the device four times. All four patients faced cardiovascular collapse and with the device, all four successfully made it through the operation to the next level of care. Since then, the device has been used three more times on subsequent deployments by SOSTs, with the same effect.

It’s remarkable to have an opportunity to give patients another chance at life, he said.

Eliason shared the same sentiments.

“If this can save one life, then it will be worth it,” he said.

A new device, known as ER-REBOA, is buying vital time for critically wounded patients. (Image credit: Prytime Medical Devices)