Saranas ’ Early Bird catches nod from FDA

Saranas said today that FDA has granted its Early Bird endovascular bleed monitoring system de novo designation. The Early Bird device includes a vascular access sheath with embedded sensors that are designed to detect and monitor bleeding from a blood vessel accidentally injured during endovascular procedures, such as TAVR, large-bore hemodynamic support device placement, or other complex cardiovascular interventions in which the femoral artery or vein is used to obtain vascular access. The technology was invented at the Texas Heart Institute. A recent study of more than 17,000 large-bore transcatheter interventions from the National Inpatient Sample Database revealed that one in five patients experienced a bleed complication, according to the Houston, Texas-based company. A 2017 article in the Journal of the American Medical Association (JAMA) reported a three times increase in mortality, two times increase in length of hospital stay and 60 percent increase in healthcare costs of procedural bleeding after percutaneous interventions using large-bore catheters, it added. “Gaining FDA approval for the Early Bird is a significant milestone for Saranas as it demonstrates our continued commitment to address an unmet need for real-time detection and monitoring of endovascular bleed complications,” said company president and CEO Zaffer Syed in a prepared statement. “As the first and only device on the market for early bleed detection, we have the potential to significantly re...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog Cardiovascular Featured Food & Drug Administration (FDA) News Well Patient Monitoring saranas Source Type: news