Sensome has announced positive outcomes from two studies evaluating its Clotlid smart guidewire system, which is designed to identify blood clots in real-time. The studies, presented at the Paris Vascular Insights Course, demonstrated Clotlid's ability to successfully identify "fresh" clot—thrombus rich in red blood cells (RBCs)—in peripheral artery disease (PAD) and differentiate it from other tissues encountered during PAD procedures. This technology could potentially enhance the efficacy of minimally invasive procedures by providing real-time, intra-operative tissue analysis.
Clotlid Technology
Sensome's system integrates a miniature electrical impedance sensor with machine learning algorithms. This allows the guidewire to identify fresh clot and differentiate it from organized clot, plaque, calcium, and other tissues in real-time during PAD procedures. The technology aims to improve operator success and patient outcomes by enabling more precise treatment decisions.
SEPARATE Study Results
The SEPARATE study evaluated 17 patients treated by Dr. Koen Deloose at AZ Sint Blasius Hospital in Belgium. Post-procedure analysis revealed a high level of agreement between Clotlid's identification of fresh clot, expert assessments, and treatment decisions appropriate for fresh clot. This suggests that the technology can accurately guide treatment strategies for PAD patients.
E-SEPARATE Study Results
The E-SEPARATE study involved 15 PAD patients in France scheduled for amputation or bypass. The study demonstrated Clotlid's ability to differentiate fresh clot from other tissues collected from these patients and examined ex-vivo. Furthermore, the study highlighted a correlation between the technology's ability to determine the RBC content of clots and a histological analysis of the same clot by an independent core lab. This correlation validates the accuracy of Clotlid in assessing clot composition.
Company Perspective
"The ability of our technology to accurately identify ‘fresh’ clot is an exciting achievement in the evolution of PAD treatment that we expect will improve operator success and patient experience," said Sensome CEO Franz Bozsak. "We have now seen positive outcomes from our initial clinical work in PAD and ischemic stroke and anticipate similarly positive findings from our current study in lung cancer. We are enthusiastic about the potential of our real-time, intra-operative tissue analysis technology to enhance the efficacy of a variety of minimally invasive procedures that are currently limited by existing imaging modalities."
