Groundbreaking SAFE MCS study of Early Bird Bleed Monitoring System is presented at CRT meeting.- Saranas Inc.

Dr. Babar Basir, Director of Acute Mechanical Circulatory Support, at Henry Ford Health System and co-principal investigator of SAFE-MCS, presented the “The Safe Surveillance of Percutaneous Coronary Intervention Under Mechanical Circulatory Support with the Saranas Early Bird Bleeding Monitoring System (SAFE-MCS) Study” as part of the late-breaking clinical trial sessions at the annual Cardiovascular Research Technologies (CRT) meeting in Washington D.C.

“I am pleased to announce a significant reduction in BARC (Bleeding Academic Research Consortium) type III or V access site bleeds in patients monitored with the EBBMS was shown compared to the historical control (4.2% vs. 12.5% in PROTECT II) which corresponded to a relative reduction in risk of 66.3%,” noted Dr. Basir. “This study is the first of its kind to specifically evaluate bleeding complications in patients undergoing protected PCI, with independently adjudicated results. These findings are clinically significant and endorse the use of EBBMS for high-risk PCI patients who are receiving MCS support.”

The study enrolled 203 patients across multiple centers in the United States. Patients undergoing complex high-risk PCI with MCS via Impella and transfemoral arterial approach were enrolled. The Early Bird Bleed Monitoring System was used in the ipsilateral femoral vein to monitor bleeding events after MCS removal.

“The SAFE-MCS study highlights the importance of prompt bleed detection and continuous monitoring to prevent severe complications and improve clinical outcomes, especially as the use of MCS increases globally,” stated Dr. Philippe Genereux, interventional cardiologist and Director of the Structural Heart Disease Program at Morristown Medical Center and co-principal investigator of SAFE-MCS. “We now have a deeper understanding of the frequency of bleeding events during such procedures with improved strategies to enhance patient safety during protected PCI.”

Approximately one in every five patients will experience a bleeding complication during large-bore endovascular procedures such as transcatheter aortic valve replacement (TAVR), endovascular aneurysm repair (EVAR), and percutaneous MCS. The average cost of a single bleeding complication incident across these large-bore procedures is approximately $18,000 with an estimated $729 million cost on the healthcare system1. The Saranas Early Bird Bleed Monitoring System is the first and only FDA-approved device for real-time monitoring of endovascular bleed complications.