FDA Grants Saranas Inc. De Novo Designation for Early Bird Bleed Monitoring System

Mar 6, 2019 | FDA Approval, Medical Device, Medical Device Regulation

Early Bird Bleed Monitoring System

Saranas Inc. released a press release announcing that their real-time detection and monitoring system for internal bleeding during endovascular procedures (Early Bird Bleed Monitoring System) was granted de novo classification by the U.S. Food and Drug Administration (FDA).

The medical device manufacturer reports that after a study reviewing 17,000 large-bore transcatheter interventions from the National Inpatient Sample Database, it was determined that 1 in 5 patients experienced a bleed complication. Additionally they note that according to a Journal of the American Medical Association (JAMA) study mortality, hospital stays, and healthcare costs associated with procedural bleeding post percutaneous interventions using large-bore catheters.

The Early Bird Monitoring Systems include a vascular access sheath with embedded bioimpedance sensors designed to detect and monitor bleeding from vessel injury which can occur during endovascular procedures such as transcatheter aortic valve replacement (TAVR), large bore hemodynamic support device placement, or other complex interventions, where the femoral artery or vein is used to obtain vascular access.  The Early Bird Monitoring System was able to detect internal bleeds with 100% sensitivity and 100% specificity.

The Early Bird Monitoring System includes a vascular access heath with embedded sensors that measure the electrical resistance across the blood vessel. By sensing change in the vessel’s electrical resistance, The Early Bird is designed to detect and monitor bleeding from a blood vessel accidentally injured during endovascular procedure.

FDA de novo classification pathway functions as an alternative means of classifying low-to moderate-risk devices. Traditionally, these devices were automatically classified as class III devices after the FDA determined that they are not substantially equivalent during review of a 510(k) application. We include a link to the FDA on this topic.

Who is Saranas Inc.? Houston-based Saranas, a medical device company, was founded in 2011. They have raised $18.7 million. On a mission to minimize complications associated with medical procedures in the interventional or surgical setting, their flagship device detects the most common complication associated with over 11 million annual catheterization procedures. The venture was founded by Mehdi Razavi MD with Texas Heart Institute. We believe they maintain a small FTE headcount of under 20.

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