US-based medical device company Saranas has announced positive results from the SAFE-MCS study (NCT05077657) of its Early Bird Bleed Monitoring System, showing that it reduces bleeding in percutaneous coronary intervention (PCI) patients using mechanical circulatory support (MCS).  

The study showed a 66.3% reduction in bleeding academic research consortium (BARC) type III or V access site bleeds among patients monitored with the system compared to historical controls – 4.2% vs 12.5% from the PROTECT II study (NCT00562016), conducted in 2012. 

The system, which gained a US Food and Drug Administration (FDA) de novo designation in 2019, incorporates a bleed detection array with integrated electrodes in a vascular access sheath. It is designed to detect and measure changes in bleeding from vessel injury during endovascular procedures, such as a transcatheter aortic valve replacement (TAVR), mechanical circulatory 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. In the first-in-human clinical study, bleed detection with the Early Bird was compared with a CT scan and the level of agreement was nearly perfect with 100% sensitivity. 

More than one in five patients experienced a bleeding complication during endovascular procedures, according to the company.  

In the announcement accompanying the results, co-principal investigator of the trial Philippe Genereux said: “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.” 

In October 2023, Philadelphia-based diagnostic company FloBio received FDA breakthrough device designation for its rapid bleeding risk diagnostic test, intended for the treatment and diagnosis of debilitating diseases or life-threatening conditions. It assists in ascertaining blood clotting status and whether a patient is taking direct oral anticoagulants (DOACs).