Saranas, Inc. announced completion of the first U.S. commercial case using the Early Bird Bleed Monitoring System for real-time detection and monitoring of endovascular bleed complications. Dr. Robert Kipperman, co-director of the Structural Heart Disease Program at Morristown Medical Center, and Dr. Bledi Zaku, cardiothoracic surgeon, successfully used the Early Bird to monitor for bleed complications during a transcatheter aortic valve replacement (TAVR) procedure conducted at the Gagnon Cardiovascular Institute, Morristown Medical Center in Morristown, N.J.
“We are excited to be the first program worldwide to incorporate the use of the Early Bird into our endovascular cases,” stated Dr. Kipperman. “The Early Bird device was easily integrated into our standard workflow and provides meaningful information to secure and optimize patient outcomes.”
The Early Bird addresses a large and growing unmet need. One in five patients experience a bleeding complication during large-bore endovascular procedures, such as transcatheter aortic valve replacement (TAVR), endovascular aneurysm repair (EVAR) and percutaneous hemodynamic support. Further, a 2017 report in the Journal of the American Medical Association (JAMA) reported a three-times increase in mortality, two-times increase in length of stay and 60 percent increase in healthcare costs due to these type bleeding complications.
Saranas was granted de novo classification by the U.S. Food and Drug Administration (FDA) for the Early Bird in March of this year. The company presented first-in-human results in May 2019 at the Society for Cardiovascular Angiography Interventions (SCAI), demonstrating that the Early Bird Bleed Monitoring System is safe, easily incorporated into standard workflows and able to detect bleeding before progression to a more severe or symptomatic phase.
The System includes a bleed detection array with integrated electrodes in a fully functional vascular access sheath. The device is designed to measure changes in bioimpedance to detect and monitor bleeding from vessel injury during endovascular procedures 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.
