Saranas® Announces Initial Enrollment of Clinical Trial Assessing the Utility of Early Bleed Detection in Patients Undergoing Mechanical Circulatory Support

Key Facts

HOUSTON--()--Saranas, Inc., has announced initiation and first patient enrollment in SAFE-MCS, a multi-center, single arm, open-label clinical trial evaluating the safety of complex high-risk percutaneous coronary intervention (PCI) using mechanical circulatory support (MCS) and surveillance with the Early Bird Bleed Monitoring System.
“We are excited to participate in SAFE-MCS as this trial aims to build the clinical evidence and key learnings on integrating early bleed detection as a viable solution to enhance safety for patients undergoing complex high-risk PCI with MCS” > > Tweet this “We are excited to participate in SAFE-MCS as this trial aims to build the clinical evidence and key learnings on integrating early bleed detection as a viable solution to enhance safety for patients undergoing complex high-risk PCI with MCS,” said Dr. Généreux, co-principal investigator of SAFE-MCS.
The Saranas Early Bird Bleed Monitoring System is the first and only FDA-approved device for real-time monitoring of endovascular bleed complications.
The Early Bird is designed to measure changes in bioimpedance to detect and monitor bleeding from vessel injury during endovascular procedures, such as a transcatheter aortic valve replacement (TAVR), hemodynamic support device placement, or other complex endovascular interventions, where the femoral artery or vein is used to obtain vascular access.