Saranas has completed enrolment in SAFE-MCS, a multicentre, 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 system is the first and only US Food and Drug Administration (FDA)-approved bleed detection system and was launched in 2019 following a de novo classification by the regulator. The device monitors and detects endovascular bleed complications through a novel application of bioimpedance sensors.
“With the global rise in utilisation of MCS, the SAFE-MCS study aims to provide valuable understanding of the actual frequency of bleeding incidents during these procedures and strategies to enhance the safety of patients undergoing complex and high-risk treatments,” stated Philippe Genereux (Morristown Medical Center, Morristown, USA), co-principal investigator of SAFE-MCS.
SAFE-MCS enrolled 184 patients across multiple centres in the USA. The primary endpoint of the study is incidence of access-site related Bleeding Academic Research Consortium (BARC) type III or V bleeding. Patients undergoing complex high-risk percutaneous coronary intervention (PCI) with MCS via Impella (Abiomed) 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.
“Prompt detection of bleeding incidents is vital to prevent complications that can severely impact patients. The insights from SAFE-MCS will offer significant insight and guidance on how continuous monitoring can improve clinical outcomes by actively addressing bleeding events,” said Babar Basir (Henry Ford Health System, Detroit, USA), co-principal investigator of SAFE-MCS.
One in every five patients will experience a bleeding complication during large-bore endovascular procedures such as transcatheter aortic valve implantation (TAVI), endovascular aneurysm repair (EVAR), and percutaneous MCS. The average cost of a single bleeding complication incident across these large-bore procedures is US$18,000 with an estimated US$729 million cost on the healthcare system.
“We are pleased to have completed enrolment of the SAFE-MCS trial,” said Saranas president and CEO Mike MacKinnon. “This marks a significant step in our journey to further establish clinical evidence for the effectiveness of the Early Bird device. Saranas is dedicated to setting a new standard for bleed detection during and after endovascular procedures, aiming to enhance patient outcomes and reduce the overall cost of healthcare.”