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The Early Bird is indicated for the introduction of catheters, catheter balloons, and other diagnostic and interventional devices into the femoral artery or femoral vein while maintaining hemostasis during diagnostic and interventional endovascular procedures. The Early Bird provides physicians with an early indication of a potential internal bleeding complication by initial detection and monitoring of extravascular fluid accumulation.

The Saranas Early Bird Bleed Monitoring System (Early Bird) is a single use, disposable, Ethylene Oxide sterilized medical device. The Early Bird now claims a 2-year shelf life. The Early Bird consists of the following: introducer sheath, user interface display (UID), for the early detection and monitoring of potential internal bleeding complications (IBCs), and a compatible dilator as shown in Figure 1. The Early Bird introducer sheath contains four embedded electrodes on the cannula and a hemostasis valve located within the sheath hub. The distal end of the sheath has a tapered leading edge which transitions smoothly to the tapered dilator, forming an atraumatic device. The dilator is radiopaque to aid in visibility under fluoroscopy during insertion. The Early Bird electrodes are connected via conductors, which transverse an independent lumen in the flush line, to a battery powered impedance analyzer, which resides in the User Interface Display (UID), depicted in Figure 2. The Early Bird is designed to monitor changes in bioimpedance due to extravascular fluid accumulation in the region where the device is inserted into the body during a percutaneous endovascular procedure.