News

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Successful Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) deployment by emergency medicine physicians for refractory non-traumatic cardiac arrest

https://www.sciencedirect.com/science/article/pii/S2666520424002352

Potential new way to treat cardiac arrest patients published in recent study that included our Landmark REBOA Catheter 

Cardiac arrest afflicts over 600,000 people annually in the United States. Rates of survival from cardiac arrest have remained stagnant for decades. REBOA is most commonly used in the management of severe hemorrhagic shock, primarily for non-compressible thoracoabdominal trauma. A growing body of evidence suggests it may serve a role in augmenting cardiac and cerebral perfusion in non-traumatic, refractory cardiac arrest. Typically, REBOA is deployed by interventional radiologists under real-time fluoroscopy. Limited data exist to demonstrate the feasibility or logistics of successful REBOA deployment in emergency departments by emergency medicine physicians. 

Study Highlights:

• Novel emergency medicine-driven REBOA protocol for refractory cardiac arrest.
• First pass success of REBOA catheterization 100%.
• ROSC achieved in 37.5 % of patients, with no catheter-related complications.
• A comprehensive REBOA training program ensures proficiency among emergency medicine physicians.
• Demonstrates feasibility of REBOA deployment using ultrasound for placement confirmation in emergency settings.

Press release for first patient use of Landmark REBOA Catheter

https://www.prnewswire.com/news-releases/new-fda-cleared-balloon-catheter-used-for-vessel-occlusion-during-patient-resuscitation-302172227.html?tc=eml_cleartime

New FDA Cleared Balloon Catheter Used for Vessel Occlusion During Patient Resuscitation

Temporary vessel occlusion a growing practice for trauma patients

SALT LAKE CITY, June 13, 2024 -- Emergency Scientific, a Utah-based medical device company specializing in innovative solutions for the emergency medicine industry, has announced the first patient use of its Landmark REBOA Catheter. The Landmark Catheter was developed for resuscitative endovascular occlusion of the aorta (REBOA), a procedure developed by the military to treat hemorrhage from non-compressible fractures of the pelvis and penetrating trauma of the abdomen and has since been adopted by civilian providers.

REBOA is also used for postpartum hemorrhage (PPH), cardiac arrest (CA), abdominal aortic aneurysm (AAA) ruptures, and gastrointestinal (GI) bleeds.

"Landmark was easy to use and easy to deliver with a smooth insertion," said Scott T. Youngquist, MD, MS, FACEP, FAEMS, FAHA, an emergency medicine physician at the University of Utah who performed the first case. "REBOA can be an important tool to aid in patient resuscitation." It is estimated that more than 60,000 people die every year in the United States from traumatic hemorrhage, making it the number one cause of death in patients under 45 years old.1,2

"We are pleased to offer another solution for physicians to treat challenging emergency hemorrhage," said Ryan Murri, Emergency Scientific's Chief Executive Officer. "With high quality emergency medicine solutions, we hope to be able to save more patients suffering life threatening injuries. We believe nobody should die from the loss of blood who could be saved with the right tools, and we look forward to continuing to serve our healthcare partners with additional novel treatment options."

The Landmark REBOA Catheter recently received FDA 510(k) clearance and is indicated for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.

Emergency Scientific is a privately held company engaged in the development, manufacturing, and distribution of novel emergency medicine solutions.

1. Latif, R.K., Clifford, S.P., Baker, J.A. et al. Traumatic hemorrhage and chain of survival. Scand J Trauma Resusc Emerg Med 31, 25 (2023). 
2. Kauvar, David S. MD; Lefering, Rolf PhD; Wade, Charles E. PhD. Impact of Hemorrhage on Trauma Outcome: An Overview of Epidemiology, Clinical Presentations, and Therapeutic Considerations. The Journal of Trauma: Injury, Infection, and Critical Care 60(6):p S3-S11, June 2006.

The convenience kit for Landmark REBOA Catheter is officially launched. It includes accessories like a 7fr sheath, a scalpel, a 30ml syringe, saline-filled syringes, a stopcock, suture and a catheter fixation device, which are needed during the REBOA procedure. We received a lot of feedback that this was necessary and so our team worked hard behind the scenes to get it out as quickly as possible. We recently shipped our first kit and look forward to continuing to provide solutions to our customers that help save time and lives.

We are excited to announce the appointment of Ryan Murri as our Chief Executive Officer to lead the commercialization efforts of Landmark REBOA Catheter. Ryan brings 13 years of sales and marketing and business experience to the team, including 10 years in the medical device industry and 3 years managing startup companies, which makes him an ideal candidate to lead Emergency Scientific going forward. Tim Nieman will stay with the company as President and COO and Marisa Donehue will continue to lead the engineering efforts.

Ryan received an undergraduate degree from Brigham Young University in Finance and an MBA from the University of Utah focusing on technology commercialization. For his MBA internship, Ryan helped manage the BioInnovations Gateway, a start-up incubator for life sciences companies, where he originally met Tim Nieman who was a tenant of the incubator at the time. Ryan then moved to the Bay Area and later Paris, France and worked for Stryker Neurovascular in sales & marketing roles for 8 years before relocating back to Utah. He transition to Merit Medical on the international sales & marketing team for a couple of years before joining a former Stryker colleague to help start and build a specialty awning manufacturing company. After 3 years and significant growth he decided to part ways and pursue other entrepreneurial interests. That's when he reconnected with Tim and the transition began.

In his limited spare time Ryan enjoys the outdoors and spending time with friends and his dog, Holland. He's also active in his church and in the community, volunteering with Junior Achievement of Utah and Big Brothers Big Sisters. He has two Little Brothers he still mentors - one in California and one in Utah.

Emergency Scientific, a pioneer in improving REBOA procedures, announced today they received United States Food & Drug Administration clearance to commercialize the Landmark REBOA Catheter system. “REBOA is an important procedure in caring for patients experiencing major bleeding,” said James R. Stone, MD, PhD, a UVA Health interventional radiologist and researcher. “It is vital that we continue to seek new and better ways to perform this life saving procedure.”

REBOA is an endovascular technique using a large diameter balloon catheters to occlude the aorta in patients suffering life threatening incompressible hemorrhage. The device is typically inserted into the patient through the femoral artery. Then the REBOA catheter is advanced superior to the aortic bifurcation and the balloon inflated to limit hemorrhage in the pelvic area or superior to the celiac artery and the balloon inflated for abdominal hemorrhage. “The Landmark REBOA catheter is intended to save lives”, said Tim Nieman, President of Emergency Scientific, Salt Lake City, Utah, USA. “Accurately placing any REBOA technology takes time which can lead to prolonged blood-loss. The Landmark catheter is designed to decrease time to place a REBOA balloon in patients and prevent further blood-loss.” 

REBOA technology was originally developed for use in trauma patients. But use of REBOA is expanding to patients suffering from post-partum hemorrhage and from cardiac arrest. The FDA cleared Landmark REBOA Catheter has a 59 cm working length and a 30mm maximum balloon diameter capable of occluding the largest vessels. The Landmark device does not require a guidewire for placement, and is designed to limit balloon migration and risk of kinking during use.

Emergency Scientific is a private company focused on novel solutions for emergency medicine.