Sensome, a leader in microsensing technology for real-time intra-operative tissue analysis, has announced promising results from two studies of its Clotild® Smart Guidewire System. The system effectively identified “fresh” clot—thrombus rich in red blood cells (RBCs)—in peripheral artery disease (PAD) patients and distinguished it from other tissues during PAD procedures. The findings from the SEPARATE and E-SEPARATE studies were shared in a late-breaking session at the Paris Vascular Insights Course.
Sensome, a leader in microsensing technology for real-time intra-operative tissue analysis, has announced positive results from two studies of its Clotild® Smart Guidewire System. The system successfully identifies “fresh” clot—thrombus rich in red blood cells (RBCs)—in peripheral artery disease (PAD) and distinguishes it from other tissue types during PAD procedures. This technology, integrated with the world’s smallest electrical impedance sensor and machine learning, offers a potential solution to the challenge of identifying clot types in PAD treatment without altering current workflow. The system can be incorporated into commonly used devices like guidewires and catheters.
PAD affects 113 million people globally, yet there is currently no easy method for physicians to determine the type of clot or tissue during treatment. Accurate tissue identification is essential for selecting the right treatment, whether it’s open surgery or endovascular procedures, and ensuring positive patient outcomes. Today, identifying “fresh” clot requires significant expertise.
The SEPARATE study, conducted with 17 patients by Dr. Koen Deloose at AZ Sint Blasius Hospital, Belgium, demonstrated the effectiveness of Sensome’s clot-sensing technology. Post-procedure analysis showed strong agreement between the technology’s identification of “fresh” clot, the expert’s assessment, and the corresponding treatment decisions.
Dr. Deloose noted, “Differentiating tissues in an obstructed vessel for successful revascularization is often limited by unclear angiographic imaging and inadequate tactile feedback. Sensome’s technology could revolutionize real-time identification of ‘fresh’ clot, improving treatment decisions for physicians at all experience levels.”
A second study, E-SEPARATE, conducted at Groupe Hospitalier Paris Saint-Joseph in France, involved 15 PAD patients and showed that Sensome’s technology could differentiate “fresh” clot from other tissues. It also correlated well with histological analysis of clots from sub-acute and chronic lesions, confirming the technology’s ability to assess RBC content accurately.
Professor Yann Gouëffic of Paris Saint-Joseph stated, “Symptoms alone are unreliable for judging clot composition in PAD patients. Sensome’s technology provides crucial information for deciding the best treatment approach, whether it’s clot aspiration, dissolution, or other methods, improving patient outcomes.”
Previous publications have also validated Sensome’s microsensor technology for predicting RBC composition in retrieved clot, showing good sensitivity and specificity.
Sensome’s CEO, Franz Bozsak, commented, “Our technology’s ability to accurately identify ‘fresh’ clot marks an exciting development in PAD treatment, enhancing operator success and patient experience. We’re optimistic about future clinical applications, including ischemic stroke and lung cancer, and the broader potential of our real-time tissue analysis technology.”
The Clotild Smart Guidewire, based on electrical impedance spectroscopy, is the world’s smallest electrical impedance sensor. It can be integrated into standard guidewires, allowing for real-time tissue analysis during minimally invasive procedures. The system has received Breakthrough Device designation from the FDA.
The Clotild Smart Guidewire System is currently an investigational device and is not approved for commercial use in the U.S. or other regions.
Sensome, a clinical-stage healthtech startup, is developing its patented microsensor technology to identify and characterize biological tissues in real time. The company is collaborating with leading medtech firms, including ASAHI INTECC, to manufacture and distribute devices incorporating its technology.
