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Saranas, a Houston, Texas firm, is releasing its novel Early Bird bleeding monitoring system in the United States, following FDA de novo approval of the device.
Intended for use during minimally invasive vascular procedures, the Early Bird helps to identify dangerous events such as ruptured or dissected vessels. Such incidents can result from using large tools, such as those used during transcatheter aortic valve replacements, and they are often undetected for too long, leading to extensive internal bleeding or blood extravasation.
Currently the only device with this kind of capability, the Early Bird uses a vascular access sheath with embedded bioimpedance sensors to detect bleeding and raise an alarm.
“Our first-in-human study demonstrated that clinical concordance with Early Bird detection and CT scans (primary endpoint) was near perfect, and the early discovery of bleed onset and progression during the procedure occurred in 31 percent of cases with 69 percent occurring post procedure,” stated Dr. Philippe Généreux, Saranas Chief Medical Officer. “Compared to the current paradigm of waiting for symptoms, which could take hours to develop, the Early Bird allows physicians to detect bleeding in real-time and take the necessary actions quickly to protect the outcomes of the procedure and aid recovery for the patient.”
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