Saranas Early Bird Bleed Monitoring System Evaluated in SAFE-MCS Study

March 11, 2024—Saranas, Inc. announced results of SAFE-MCS, a multicenter clinical study 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 (EBBMS).

SAFE-MCS enrolled 203 patients across multiple centers in the United States. Patients in the study were treated with complex high-risk PCI with MCS via Impella (Abiomed, Inc.) and a transfemoral arterial approach. The EBBMS was used in the ipsilateral femoral vein to monitor bleeding events after MCS removal.

Babar Basir, DO, and Philippe Généreux, MD, are Coprincipal Investigators of SAFE-MCS.

Dr. Basir presented the findings during the late-breaking clinical trial sessions at CRT 2024, the Cardiovascular Research Technologies annual meeting held March 9-12 in Washington, DC.

“I am pleased to announce a significant reduction in Bleeding Academic Research Consortium type III or V access site bleeds in patients monitored with the EBBMS compared to the historical control (4.2% vs 12.5% in PROTECT II), which corresponded to a relative reduction in risk of 66.3%,” stated Dr. Basir in the company’s press release.

Dr. Basir further commented, “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.”

Dr. Généreux added, “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. 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.”

Dr. Basir is Director of Acute Mechanical Circulatory Support at Henry Ford Health System in Detroit, Michigan. Dr. Généreux is Director of the Structural Heart Disease Program at Morristown Medical Center in Morristown, New Jersey.

According to the company, the Saranas EBBMS is FDA approved for real-time monitoring of endovascular bleed complications. The system includes a bleed detection array with integrated electrodes in a fully functional vascular access sheath. It was launched in 2019 after receiving FDA de novo classification.

The EBBMS is designed to measure changes in bioimpedance to detect and monitor bleeding from vessel injury during endovascular procedures, such as MCS device placement, transcatheter aortic valve replacement, 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, noted Saranas in the press release.