The Early Bird Bleed Monitoring System, which can detect internal bleeding during endovascular procedures, has been granted de novo classification by the FDA. The approval was announced March 5 by Saranas, the device’s manufacturer.
The announcement points to a recent study which found 1 in 5 patients undergoing large-bore transcatheter interventions experienced a bleeding complication, which can triple the risk of mortality, increase the duration of hospital stays and drive up healthcare costs to treat those issues.
According to Saranas CEO and President Zaffer Syed, Early Bird is the only device on the market for early bleeding detection during these procedures. The company plans to roll out the product commercially in select centers of excellence in the U.S.
“Peri-procedural bleeding associated with endovascular procedures has a significant impact on patient safety and adds incremental costs to the healthcare system with longer hospital stays and additional interventional treatment,” Philippe Généreux, MD, Saranas’ chief medical officer, said in a statement. “I firmly believe the Early Bird Bleed Monitoring System will help protect, and in some cases, save the lives of patients undergoing an endovascular procedure by allowing physicians to detect the onset of bleeding early and take appropriate steps to address the bleed before detrimental, irreversible and life-threatening consequences occur.”
Early Bird includes a vascular access sheath equipped with sensors to monitor potential bleeding during select procedures which use transfemoral access, including transcatheter aortic valve replacement. The sensors detect when the electrical resistance changes across blood vessels, which may indicate blood is pooling outside the vessels. Audible and visual alerts are issued when there’s a possible bleed.