HOUSTON--(BUSINESS WIRE)--Saranas, Inc. announced today the compelling results of SAFE-MCS, a multi-center clinical study 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 (EBBMS). Dr. Babar Basir, Director of Acute Mechanical Circulatory Support, at Henry Ford Health System and co-principal investigator of SAFE-MCS, presented “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.
“We would like to thank the excellent team of physicians and coordinators who contributed to the success of this study,” commented Mike MacKinnon, CEO and President of Saranas. “This represents an important advancement in our mission to continue building the clinical proof supporting the effectiveness of the Early Bird device. Saranas is dedicated to establishing a new benchmark for bleed detection during and after endovascular procedures, with the goal of improving patient outcomes and decreasing healthcare expenses overall.”
About the Early Bird Bleed Monitoring System
The Early Bird Bleed Monitoring System includes a bleed detection array with integrated electrodes in a fully functional vascular access sheath. It 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), mechanical circulatory support (MCS) device placement, or other complex endovascular interventions, where the femoral artery or vein is used to obtain vascular access. Visual and audible indicators on the Early Bird notify the clinician of the onset and progression of bleeding events. In the FIH clinical study, bleed detection with the Early Bird was compared with a CT scan, the gold standard, and level of agreement was nearly perfect with 100% sensitivity2.
About Saranas, Inc.
Saranas, Inc. is a privately held Houston-based medical device company focused on improving patient outcomes through early detection and monitoring of internal bleeding complications. The company’s patented Early Bird Bleed Monitoring System for vascular access procedures enables physicians to mitigate downstream consequences by addressing bleeding complications immediately, improving patient outcomes, and lowering healthcare costs. For more information, please visit www.saranas.com.
- Redfors B et al. Mortality, length of stay, and cost implications of procedural bleeding after percutaneous interventions using large-bore catheters. JAMA Cardiol. 2017 Jul 1;2(7):798-802.
- Genereux P et al. First-in-Human Study of the Saranas Early Bird Bleed Monitoring System for the Detection of Endovascular Procedure-Related Bleeding Events. J Invasive Cardiol. 2020 Jul;32(7):255-261. Epub 2020 Jun 8.
