Saranas Reaches Midpoint for Enrollment in Clinical Trial Assessing the Utility of Early Bleed Detection in Patients Undergoing Mechanical Circulatory Support

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The Early Bird Bleed Monitoring System is the first and only FDA-approved bleed detection system.

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Monday, March 27, 2023
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Cardiology, Surgery, Health, FDA, Medical Devices, Health Technology, Clinical Trials, Other Health, CRF, Bleeding, De novo, Morristown Medical Center, Classification, BARC, Henry Ford Health, Structural heart disease, PCI, Incidence, Henry Ford, Patient, Impella, TAVR, Early Bird, Research, The Early Bird, MCS, Early, EVAR, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, III, Aortic stenosis, Food, Safety, Medical device, Birth control
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TEXAS, UNITED STATES, NORTH AMERICA
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SARANAS, SARANAS, INC.
Summary
Key Points: 
  • The Early Bird Bleed Monitoring System is the first and only FDA-approved bleed detection system.
  • Patients undergoing complex high-risk PCI with mechanical circulatory support (MCS) via Impella and transfemoral arterial approach are enrolled as study participants.
  • “This is an important milestone in our efforts to continue building clinical evidence to support the utility of the Early Bird device.
  • The Saranas Early Bird Bleed Monitoring System is the first and only FDA-approved device for real-time monitoring of endovascular bleed complications.


Saranas, Inc. announced today that it has reached the midpoint for 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. The Early Bird Bleed Monitoring System is the first and only FDA-approved bleed detection system. It was launched in 2019 following a De Novo classification by the U.S. Food and Drug Administration. The device monitors and detects endovascular bleed complications through a novel application of bioimpedance sensors.

“As the use of MCS increases worldwide, the SAFE-MCS study will bring important insight on what the true rate of bleeding events are during those procedures, and how to improve safety outcomes of patients undergoing complex and high-risk interventions,” 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.

SAFE-MCS will enroll up to 265 patients across multiple centers in the United States. The primary endpoint of the study is incidence of access-site related BARC (Bleeding Academic Research Consortium) type III or V bleeding. Patients undergoing complex high-risk PCI with mechanical circulatory support (MCS) via Impella and transfemoral arterial approach are enrolled as study participants. The Early Bird Bleed Monitoring System is used in the ipsilateral femoral vein to monitor bleeding events after MCS removal.

“Timely identification of bleeding events is crucial in preventing adverse events that can have serious consequences for patients. The data from SAFE-MCS will provide meaningful guidance on how real-time monitoring can improve clinical outcomes through a proactive approach to managing bleeding risk,” said Dr. Babar Basir, Director of Acute Mechanical Circulatory Support, at Henry Ford Health System and co-principal investigator of SAFE-MCS.

Saranas is partnering with the Cardiovascular Research Foundation (CRF) Clinical Trials Center to assess cost savings associated with the Early Bird in the SAFE-MCS trial. “As health systems are highly sensitive to the burden of incremental costs from procedural complications, it is more important than ever to quantify the economic value of innovative technologies like early bleed detection,” said Dr. David Cohen, Director of Clinical and Outcomes Research at CRF.

“We are pleased to announce that we have reached the midpoint for enrollment in the SAFE-MCS trial,” said Saranas President and CEO Mike MacKinnon. “This is an important milestone in our efforts to continue building clinical evidence to support the utility of the Early Bird device. Saranas is committed to establishing a new standard of care for bleed detection during and after endovascular procedures to improve patient outcomes and reduce healthcare costs.”

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.

To learn more about SAFE-MCS, please visit the study record on clinicaltrials.gov.

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.

1.

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.

2.

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.

 

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