Saranas Early Bird Bleed Monitoring System Evaluated in SAFE-MCS Trial of High-Risk PCI Using Mechanical Circulatory Support

December 6, 2021—Saranas, Inc. announced the initiation of the SAFE-MCS clinical trial evaluating the safety of complex high-risk percutaneous coronary intervention (PCI) using mechanical circulatory support (MCS) and surveillance with the company’s Early Bird bleed monitoring system. The multicenter, single-arm, open-label trial will enroll up to 265 patients at centers in the United States.

According to Saranas, the primary endpoint of the study is incidence of access site–related Bleeding Academic Research Consortium (BARC) type III or V bleeding. The study will be composed of patients undergoing complex high-risk PCI with MCS via Impella (Abiomed, Inc.) and transfemoral arterial approach. The Early Bird system will be used in the ipsilateral femoral vein to monitor bleeding events after MCS removal.

The Coprincipal Investigators of the SAFE-MCS trial are Philippe Généreux, MD, and Mir Babar Basir, MD. Dr. Généreux is Co-Director of the Structural Heart Program at Atlantic Health System’s Morristown Medical Center in Morristown, New Jersey. Dr. Basir is Director of Acute Mechanical Circulatory Support at Henry Ford Health System in Detroit, Michigan.

The first patient in the SAFE-MCS trial was enrolled by Dr. Généreux and Dimitrios Karmpaliotis, MD, at Morristown Medical Center. Dr. Karmpaliotis is Medical Director of the Cardiovascular Rescue and Recovery Program and the Advanced Coronary Therapeutics and Chronic Total Occlusions Program at Morristown Medical Center.

In the Saranas press release, Dr. Généreux commented, “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.”

Dr. Basir added, “As the field of minimally invasive, catheter-based procedures continues to advance, patient safety is paramount. This study will collect comprehensive procedural data in patients undergoing PCI with MCS. The data will undergo independent adjudication of clinical events to provide meaningful guidance on how real-time bleed monitoring can improve clinical outcomes.”

Saranas further noted it is partnering with the Cardiovascular Research Foundation (CRF) Clinical Trials Center to assess cost savings associated with Early Bird in the SAFE-MCS trial. David Cohen, MD, Director of Clinical and Outcomes Research at CRF, commented in the Saranas press release, “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.”

Saranas stated that the Early Bird system includes a bleed detection array with integrated electrodes in a fully functional vascular access sheath. The Early Bird is designed to measure changes in bioimpedance to detect and monitor bleeding from vessel injury during endovascular procedures, such as transcatheter aortic valve replacement, hemodynamic support 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.

The Saranas Early Bird bleed monitoring system is FDA approved for real-time monitoring of endovascular bleed complications, advised the company.