The first of its kind device for detecting early internal bleeding developed by Texas-based Medical devices maker Saranas Inc has received the de novo approval from US Food and Drug Administration.
The Early Bird Bleed Monitoring System includes a vascular access sheath with embedded bioimpedance sensors that are designed to detect and monitor bleeding from ruptured vessel. Such bleeding typically occur during non-invasive endovascular procedures such as a transcatheter aortic valve replacement (TAVR), large bore hemodynamic support device placement, or other complex cardiovascular interventions, where the femoral artery or vein is used to obtain vascular access.
Though generally safer, minimally invasive vascular procedures may have possible complications where an internal bleeding or blood extravasation from a ruptured or dissected vessel could occur while working with large instruments and devices and may remain unnoticed until the situation is already dire.
The De Novo channel for novel medical devices allows the FDA to conduct a rigorous review of new technologies so that patients have timely access to safe and effective medical devices to improve their health.
In an animal study to support FDA review of the device’s effectiveness, the Early Bird claims to have been able to detect internal bleeds with 100% sensitivity and specificity.
Saranas’ device is currently being piloted in a few clinical centers and is planning to begin commercial rollout of the soon.