Saranas’ SAFE-MCS Trial Reaches Enrollment Midpoint

March 27, 2023—Saranas, Inc. announced that it has reached the midpoint for enrollment in the SAFE-MCS clinical trial. The multicenter, single-arm, open-label trial is evaluating the safety of complex high-risk percutaneous coronary intervention (PCI) using mechanical circulatory support (MCS) and surveillance with the company’s FDA-approved Early Bird bleed monitoring system.

In December 2021, the company announced the initiation of the trial.

According to the company, the Early Bird device monitors and detects endovascular bleed complications through a novel application of bioimpedance sensors. The Early Bird system was launched in 2019 after receiving a de novo classification by the FDA.

Saranas advised that SAFE-MCS will enroll up to 265 patients across multiple centers in the United States. The primary endpoint of the study is the incidence of access-site-related Bleeding Academic Research Consortium (BARC) type III or V bleeding. The study is enrolling patients undergoing complex high-risk PCI with MCS via Impella (Abiomed, Inc.) and transfemoral arterial approach. The Early Bird bleed monitoring system is 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 Babar Basir, MD. Dr. Généreux is an interventional cardiologist and Director of the Structural Heart Disease Program at Morristown Medical Center in Morristown, New Jersey. Dr. Basir is Director of Acute Mechanical Circulatory Support at Henry Ford Health System in Detroit, Michigan.

“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,” commented Dr. Généreux in the company’s press release.

Dr. Basir added, “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.”

Saranas noted that it 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.

David Cohen, MD, Director of Clinical and Outcomes Research at CRF, stated in the 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.”