One of the studies determined technology’s ability to distinguish ‘fresh’ clots from other tissues. Credit: NMK-Studio / Shutterstock.

Sensome’s Clotild Smart Guidewire System has shown promise in identifying ‘fresh’ clots in individuals with peripheral artery disease (PAD) according to the positive outcomes from the SEPARATE and E-SEPARATE studies.

The Clotild system features the smallest electrical impedance sensor and machine learning, and can instantly distinguish between various clots and other tissues encountered during PAD procedures.

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This clot-sensing technology, which can be incorporated into devices such as catheters and guidewires, aims to provide real-time, individualised treatment information without altering current workflows.

In the SEPARATE study, the head of vascular surgery at AZ Sint Blasius Hospital, Belgium, Dr Koen Deloose, treated 17 subjects who underwent treatment using the Sensome clot-sensing technology.

The study confirmed a high level of agreement between the technology’s identification of fresh clots, the expert’s assessment, and the subsequent treatment decisions.

A second study, E-SEPARATE, included 15 subjects and was conducted at Groupe Hospitalier Paris Saint-Joseph in France. This study highlighted the technology’s ability to distinguish ‘fresh’ clots from other tissues and showed a correlation between the technology’s determination of the red blood cell (RBC) content of clots and histological analysis by an external core lab.

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The Clotild guidewire measures the electrophysiological characteristics of surrounding fluids or tissues, analysed by the models of the company.

Sensome CEO Franz Bozsak said: “The ability of our technology to accurately identify ‘fresh’ clots is an exciting achievement in the evolution of PAD treatment that we expect will improve operator success and patient experience.

“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.”

Although the system has received the US Food and Drug Administration’s breakthrough device designation, it remains an investigational device and is not yet approved for commercial use in the US or any other region.