Sensome has shared promising results from two recent studies assessing its innovative Clotlid smart guidewire system designed to detect blood clots. The findings emphasize Clotlid’s capability in accurately recognizing “fresh” thrombus — rich in red blood cells (RBCs) — specifically in peripheral artery disease (PAD) cases, and distinguishing it from other kinds of tissue encountered during such procedures. The SEPARATE and E-SEPARATE study findings were unveiled at the Paris Vascular Insights Conference.
The company reported that this novel system incorporates the smallest electrical impedance sensor in the world, paired with machine learning. Tailored for PAD applications, it identifies fresh clots, differentiates them from organized clots, as well as from plaque, calcification, and other tissues in real-time. This technology shows potential to detect fresh clots during medical procedures without altering existing workflows.
Insights into the Sensome Studies
The SEPARATE trial involved 17 patients treated by Dr. Koen Deloose at the AZ Sint Blasius Hospital in Belgium. Post-procedure analysis indicated a high correlation between the smart guidewire’s clot identification capabilities, expert analyses, and the appropriate treatment choices for fresh clots.
Meanwhile, the E-SEPARATE study engaged 15 PAD patients who were either undergoing amputation or bypass surgery in France. This study illustrated the technology’s proficiency in differentiating fresh clots from other tissue types, collected and examined outside the body. Additionally, it revealed a connection between the method’s ability to determine the RBC content in PAD patients’ clots, with both sub-acute and chronic conditions, and a histological analysis by an independent core laboratory.
“Our technology’s precise capacity to identify ‘fresh’ clots marks a significant milestone in advancing PAD treatments, which we believe will enhance the success rates for operators and improve patient experiences,” remarked Sensome CEO Franz Bozsak. “With encouraging outcomes from our primary clinical work on PAD and ischemic stroke, we anticipate similar success with our ongoing lung cancer study. We are optimistic about the potential of our real-time, intra-operative tissue analysis technology to improve the effectiveness of numerous minimally invasive procedures, which current imaging modalities limit.”