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June 10, 2020

Studies Published on Clinical Use of Saranas Early Bird Bleed Monitoring System

June 10, 2020—Saranas, Inc. announced the online publication of two studies in Journal of Invasive Cardiology demonstrating the accuracy and performance of the company’s Early Bird bleed monitoring system for the monitoring and early detection of internal bleed complications during endovascular procedures.

According to the company, the studies provide evidence of the Early Bird’s reliability to detect the early onset and progression of bleeding events during endovascular procedures.

In the first study, “Safety and Accuracy of a Novel Bioimpedance System for Real-Time Detection and Monitoring of Endovascular Procedure-Related Bleeding in a Porcine Model,” Philippe Généreux, MD, et al evaluated the performance of the Early Bird to detect endovascular bleeding through a validated animal bleed model. The investigators concluded that the Early Bird could detect the onset and progression of bleeds with 100% sensitivity and 100% specificity.

The second study, “First-in-Human Study of the Saranas Early Bird Bleed Monitoring System for the Detection of Endovascular Procedure-Related Bleeding Events,” by Dr. Généreux, et al, used the Early Bird during and after endovascular procedures in 60 patients across five centers in the United States. The study’s primary endpoint was the level of agreement in bleeding detection between the Saranas Early Bird and postprocedural CT. The clinical study results validate the effectiveness of the Early Bird with a high level of agreement (Cohen’s kappa = 0.84) when compared with independently reviewed postprocedural CT scans.

In the Saranas announcement, Dr. Généreux commented, “Among a population of all-comer patients undergoing a broad variety of endovascular procedures, the Early Bird was safe, easily incorporated into our standard workflow, and demonstrated the capacity to detect bleeding before the progression to a more severe or symptomatic phase.”

In 2019, Saranas announced the commercial launch of the Early Bird bleed monitoring system in the United States. The company announced de novo classification from the FDA in March 2019.

According to the company, the Early Bird device includes a Bleed Detection Array with integrated electrodes in a fully functional vascular access sheath. The system is designed to measure changes in bioimpedance to detect and monitor bleeding from vessel injury during endovascular procedures, such as transcatheter aortic valve replacement, hemodynamic support device placement, or other complex endovascular interventions where the femoral artery or vein is used to achieve vascular access. Visual and audible indicators on the Early Bird notify the clinician of the onset and progression of bleeding events.

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