Saranas Launches Early Bird Bleed Monitoring System in the United States

September 18, 2019—Saranas, Inc. announced the commercial launch of the Early Bird bleed monitoring system in the United States. The Early Bird device, which uses bioimpedance sensors for the monitoring and early detection of endovascular bleed complications, received de novo classification from the FDA in March 2019.

According to the company, the Early Bird system allows physicians to monitor the bleed status of a patient during and after procedures, receive timely notifications of actual bleeds, and potentially reduce the severity of bleeding complications and resulting costs, while protecting clinical outcomes in patients undergoing endovascular procedures.

The Early Bird bleed monitoring 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.

Saranas will introduce the device at TCT 2019, the Transcatheter Cardiovascular Therapeutics conference held September 25–29 in San Francisco, California. At TCT, initial clinical experience with the Early Bird and its potential role in protecting outcomes with real-time bleed monitoring will be reviewed in a presentation on September 27 during a Breakfast Satellite program: “Optimization of Vessel Access and Closure in Large-Bore Catheter Procedures: Tips and Tricks Case-Based Review.”

Saranas stated that first-in-human results demonstrated 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 study showed near-perfect clinical concordance with Early Bird detection and CT scans (primary endpoint). The early discovery of bleed onset and progression during the procedure occurred in 31% of cases, with 69% occurring postprocedure. The findings were presented at SCAI 2019, the Society for Cardiovascular Angiography Interventions annual scientific sessions held May 19–22 in Las Vegas, Nevada.