The Cardiac & Vascular Institute and North Florida Regional Medical Center Join Together in a Clinical Trial to Test an Innovative Artificial Intelligence (AI) Device

Jan. 10, 2019 – The Cardiac & Vascular Institute (TCAVI) and North Florida Regional Medical Center (NFRMC) collaborated this week to test an artificial intelligence (AI) device designed to alert clinicians to bleeding episodes during endovascular procedures.

According to a press release, the AI device, (named Early Bird™ Bleed Monitoring System by Houston-based company Saranas™), uses a sheath embedded with an array of electrodes used to detect when the electrical resistance changes across blood vessels. By sensing a change in the vessel’s electrical resistance, the device is designed to detect, monitor and signal blood pooling outside of vessels, triggering audible and visual notifications that alert the care team to a possible bleed.

“Severe, life threatening bleeding remains a significant problem, which limits our ability to safely complete our large bore transcatheter procedures,” says Interventional Cardiologist Mark Tulli, M.D. of The Cardiac & Vascular Institute. “These procedures are life saving for the most complex and very sickest of patients, who have few options to help make them better. Even the smallest of bleed, in these sick patients, is not tolerated well. Our hope is that the Early Bird™ Bleeding Monitoring Device will help detect bleeding before it is clinically evident, helping us treat these complex patients and achieving the best outcomes.”

“With the expanding indications for transcatheter aortic valve replacement and other similar large bore arterial access procedures, the overall benefit to patients is immeasurable. However, the Achilles’ heel remains careful monitoring for arterial access site complications,” according to Charles Klodell, M.D., Cardiothoracic Surgeon at North Florida Regional Medical Center and Principle Investigator on this clinical trial. “The Early Bird Device has the potential to help us recognize any abnormalities early and quickly develop mitigating strategies to mitigate any of the adverse consequences that may occur. This device will play a key role in allowing us to monitor for bleeding in real-time making these procedures safer in the future.”

With vascular access procedures on the rise, the Early Bird Bleed Monitoring System is designed to protect, and in some cases, save the lives of patients undergoing an endovascular procedure by using embedded sensors designed to detect and monitor bleeding from a blood vessel accidentally injured during endovascular procedures. If detected early, bleeds can be stopped or even prevented, which can help to decrease procedural complications, healthcare costs and the length of stay in the hospital after a procedure.

Sheaths are currently used in cardiac and vascular procedures to keep vessels open, which means that this device will be applicable to existing operations. The Early Bird Bleed Monitoring System is not yet cleared by the U.S. Food and Drug Administration and is currently available for investigational use only.

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