HOUSTON--(June 23, 2020)--Saranas, Inc., developer of the Early Bird Bleed Monitoring System for the monitoring and early detection of internal bleed complications during endovascular procedures, announced the online publication of two peer-reviewed articles highlighting the system’s accuracy and performance. The publications provide evidence of the Early Bird’s reliability to detect the early onset and progression of bleeding events during endovascular procedures.
“These two published studies underscore our commitment to conducting rigorous scientific and clinical studies that demonstrates the value and utility of the Early Bird Bleed Monitoring System”
One paper, entitled “Safety and Accuracy of a Novel Bioimpedance System for Real-Time Detection and Monitoring of Endovascular Procedure-Related Bleeding in a Porcine Model,” was published online in the Journal of Invasive Cardiology (https://bit.ly/2XK0qj8). The paper contains results from the study, which evaluated the performance of the Early Bird to detect endovascular bleeding through a validated animal bleed model. The study concluded that the Early Bird could detect the onset and progression of bleeds with 100% sensitivity as well as 100% specificity.
A second paper, entitled “First-in-Human Study of the Saranas Early Bird® Bleed Monitoring System for the Detection of Endovascular Procedure-Related Bleeding Events,” was published online in the Journal of Invasive Cardiology (https://bit.ly/2AdKEEh). The Early Bird was used during and after endovascular procedures in 60 patients across 5 centers in the United States. The primary endpoint was the level of agreement in bleeding detection between the Saranas Early Bird and post-procedural computed tomography (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 to independently reviewed post-procedural CT scans.
“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,” said Philippe Généreux, MD (Morristown Medical Center, NJ), the study’s primary author.
“These two published studies underscore our commitment to conducting rigorous scientific and clinical studies that demonstrates the value and utility of the Early Bird Bleed Monitoring System,” said Saranas President and CEO James Reinstein. “As the first and only device on the market for early bleed detection, the Early Bird has the potential to significantly reduce the severity of bleeding complications and resulting costs, while improving clinical outcomes in patients undergoing endovascular procedures.”
About the Early Bird Bleed Monitoring System
The Early Bird Bleed Monitoring System includes a Bleed Detection Array with integrated electrodes in a fully functional vascular access sheath. The Early Bird is designed to measure changes in bioimpedance to detect and monitor bleeding from vessel injury during endovascular procedures, such as a transcatheter aortic valve replacement (TAVR), hemodynamic support device placement, or other complex endovascular interventions, where the femoral artery or vein is used to obtain vascular access. Visual and audible indicators on the Early Bird notify the clinician of the onset and progression of bleeding events.
Saranas is a privately held Houston-based medical device company focused on improving patient outcomes through early detection and monitoring of internal bleeding complications. The company’s patented Early Bird Bleed Monitoring System for vascular access procedures enables physicians to mitigate downstream consequences by addressing bleeding complications immediately, improving patient outcomes and lowering healthcare costs. For more information, please visit www.saranas.com.