The US Food and Drug Administration (FDA) has granted de novo designation to Saranas’ Early Bird Bleed Monitoring System, which is designed to detect and reduce bleeding complications.

The system comprises a vascular access sheath that is embedded with bioimpedance sensors for the identification and monitoring of bleeding from vessel injury.

Early Bird is intended for endovascular procedures such as transcatheter aortic valve replacement (TAVR) and use of large-bore hemodynamic support devices.

When tested in animals, the monitoring system demonstrated the ability to detect internal bleeds with 100% sensitivity and specificity. This study was intended to support the FDA’s review of Early Bird’s effectiveness.

“We have the potential to significantly reduce bleeding complications and related healthcare costs.”

Saranas president and CEO Zaffer Syed said: “Gaining FDA approval for the Early Bird is a significant milestone for Saranas as it demonstrates our continued commitment to address an unmet need for real-time detection and monitoring of endovascular bleed complications.

“As the first and only device on the market for early bleed detection, we have the potential to significantly reduce bleeding complications and related healthcare costs, while improving clinical outcomes in patients undergoing endovascular procedures.”

The device is currently available under a pilot scheme at various centres that will determine its versatility and potential for enhancing patient safety via improved bleed status monitoring during and after endovascular access procedures. Saranas intends to commercially launch the device across the US.

A recent study of more than 17,000 large-bore transcatheter interventions from the National Inpatient Sample Database revealed that more than one in five patients experienced a bleed complication.

According to a report published in the Journal of the American Medical Association (JAMA) in 2017, procedural bleeding following percutaneous interventions with large-bore catheters led to an increase in mortality and hospital stay, as well as a 60% rise in healthcare costs.