Sensome today announced positive results from two studies of its Clotlid smart guidewire system for identifying blood clots.
Outcomes highlighted 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 tissue encountered during PAD procedures. Investigators presented results from the SEPARATE and E-SEPARATE studies at the Paris Vascular Insights Course.
The company said its system integrates the world’s smallest electrical impedance sensor with machine learning. For PAD, it helps identify “fresh” clot and differentiate it from organized clot, plus plaque, calcium and other tissue in real-time. The technology could potentially enable the identification of fresh clot during a procedure without changing workflows.
More about the Sensome studies
Sensome’s SEPARATE study evaluated 17 patients treated by Dr. Koen Deloose of AZ Sint Blasius Hospital in Belgium. The study showed in a post-procedure analysis that there was a high level of agreement between the technology’s identification of fresh clot, the expert’s assessment of fresh clot and the treatment decisions appropriate for fresh clot.
The E-SEPARATE study looked at 15 PAD patients scheduled for amputation or bypass in France. The study showed the technology’s ability to differentiate fresh clot from other tissue collected from these PAD patients and examined ex-vivo. It also highlighted a correlation between the technology’s ability to determine the RBC content of clots collected from PAD patients with sub-acute and chronic lesions and a histological analysis of the same clot by an outside core lab.
“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.”
