Authors: Brendan Jones, MD; Nova Szoka, MD, FACS, FASMBS
Saranas received FDA de novo approval for Early Bird Bleed Monitoring System on March 5, 2019. This device is a Class II device.
The Early Bird Bleed Monitoring System is a first-of-its-kind device on the market to allow for early detection of endovascular bleeding complications. It is intended to detect vascular injury following large bore endovascular procedures before patients demonstrate clinical signs of hemodynamic instability. The device can detect such injuries as blood vessel rupture or dissection.
The system includes a vascular access sheath with embedded sensors that measure electrical resistance across the blood vessel. Following endovascular procedures the device can detect and monitor changes in vascular bioimpedance due to accumulation of extravascular fluid. With vessel trauma, the bioimpedance decreases and when the rate of decline reaches a prescribed slope threshold, an alarm on the device is triggered. When an alarm is triggered the device uses that data to monitor for the progression of the bleed. If the bleed progresses, different levels of alarms will sound. The device is available with a 6 or 8 Fr sheath and can also be utilized in procedures requiring larger (9-25 Fr) access sheaths.
A prospective, self-controlled animal study was performed to review the device’s effectiveness with 100% sensitivity and specificity to detect internal bleeds. The device successfully identified bleed progression with statistically significant increase in volume detected at each bleed indicator level. The first in-human study with 60 patients (TAVR 67%, PCI 13%, Impella 8%, Balloon aortic valvuloplasty 7%, transcatheter mitral valve replacement 2%, EVAR 2%, and MitraClip 2%) demonstrated clinical concordance with the device and CT scans. Multiple centers are currently piloting the device.
For procedures in which the femoral artery and/or vein are accessed.
For procedures requiring the introduction of catheters, catheter balloons, and other diagnostic and interventional devices into the femoral artery or vein.
Examples of these procedures include: Percutaneous transcatheter intervention, transcatheter structural heart procedures, percutaneous ventricular assist device, extracorporeal membrane oxygenation, endovascular aneurysm repair, thoracic endovascular aneurysm repair, and other procedures utilizing introducer sheaths.
Not indicated for use in non-endovascular procedures.