FDA Grants Saranas De Novo Designation for the Early Bird Bleed Monitoring System
March 5, 2019—Saranas Inc. announced that it has been granted de novo classification by the FDA for its Early Bird bleed monitoring system for interventions where the femoral artery or vein is used to obtain vascular access.
According to the company, the Early Bird device includes a vascular access sheath with embedded bioimpedance sensors designed to detect and monitor bleeding from vessel injury that may occur during endovascular procedures, such as transcatheter aortic valve replacement, large-bore hemodynamic support device placement, or other complex cardiovascular interventions. In an animal study to support FDA review of the device’s effectiveness, the Early Bird was able to detect internal bleeds with 100% sensitivity and 100% specificity.
Saranas advised that the Early Bird bleed monitoring system is currently being piloted in multiple centers to assess the versatility of the device to potentially increase patient safety with improved bleed status monitoring during and after endovascular access procedures. The company plans to commercially launch the device in select centers of excellence across the United States.
Dimitrios Karmpaliotis, MD, commented in the Saranas announcement, “Bleeding remains an Achilles' heel of advancing minimally invasive, catheter-based procedures. The Early Bird will play a key role in making these procedures safer in the future by providing physicians bleed monitoring in real time.”