Though generally safer than open surgeries, minimally invasive vascular procedures have a number of possible complications. One major complication is an internal bleeding or blood extravasation from a ruptured or dissected vessel, typically caused when working with large instruments and devices, and something that a physician may not even notice until the situation is already dire.
Saranas, a company out of Houston, Texas, just won FDA de novo approval for its Early Bird bleed monitoring system. The device is the only product of its kind and it is hoped that it will help to save patients when transcatheter procedures take an unexpected turn.
The system works off of a vascular access sheath with embedded bioimpedance sensors that can detect a bleeding event and set off an alarm on the control unit.
The device is currently being piloted in a few clinical centers with the company having plans to soon begin commercial rollout of the technology.
Here’s a short animation showing off the Early Bird’s usage: