Sensome’s Clotild clot-sensing guidewire shows promise in peripheral artery disease treatment studies

A breakthrough innovation in the treatment of peripheral artery disease (PAD) could soon transform clinical practice, offering clinicians a real-time solution to accurately identify clot composition. Sensome, a leader in healthcare technology innovation, announced promising results from two studies evaluating its Clotild Smart Guidewire System. The findings, shared at the prestigious Paris Vascular Insights Course, demonstrate the system’s ability to detect “fresh” clots – those rich in red blood cells (RBCs) – with unprecedented accuracy.

This cutting-edge technology addresses a critical challenge in peripheral artery disease treatment: distinguishing between fresh clots, organized clots, and other tissues like plaque or calcium during procedures. Accurate tissue identification is essential for selecting the most effective intervention, from clot aspiration to open surgery, and could lead to improved patient outcomes.

What Makes Peripheral Artery Disease Treatment So Complex?

Peripheral artery disease, which affects over 113 million individuals globally, often presents with complications stemming from obstructed blood flow in the arteries. Treatment involves revascularization to restore circulation, but determining the type of blockage remains a major obstacle. Today, clinicians rely on angiographic imaging, patient history, and tactile guidewire feedback – methods that are often subjective and imprecise.

The ability to accurately identify the type of clot in real time is a game-changer, explained Dr. Koen Deloose, Head of Vascular Surgery at AZ Sint Blasius Hospital in Belgium. He noted that treatment outcomes hinge on identifying RBC-rich fresh clots versus organized clots or calcified lesions. Misidentification can delay optimal treatment, impacting the long-term success of interventions.

What Did the Studies Reveal About the Clotild Guidewire?

The SEPARATE and E-SEPARATE studies explored how Sensome’s clot-sensing guidewire system performs in real-world scenarios.

SEPARATE Study Findings

Conducted with 17 peripheral artery disease patients, the SEPARATE study evaluated the guidewire’s ability to identify fresh clots during procedures. Led by Dr. Deloose, the study demonstrated that the system’s real-time assessments aligned closely with expert evaluations. This level of precision could reduce reliance on operator experience and improve PAD treatment decisions across skill levels.

E-SEPARATE Study Findings

At Groupe Hospitalier Paris Saint-Joseph in France, researchers tested the guidewire’s ability to differentiate tissue types in clots retrieved from peripheral artery disease patients. Findings showed excellent accuracy in distinguishing fresh clots from organized clots in chronic lesions. Moreover, histological analysis confirmed that fresh clots could appear even in chronic or sub-acute lesions, challenging traditional assumptions about clot composition based solely on symptom onset.

How Does the Clotild Guidewire Work?

The Clotild Smart Guidewire integrates advanced microsensing technology with machine learning to deliver instant intra-operative insights. Using electrical impedance spectroscopy, the guidewire measures tissue characteristics surrounding the sensor. This miniaturized technology – the smallest of its kind – fits seamlessly onto standard guidewires without disrupting the workflow.

For peripheral artery disease, this system enables clinicians to:

Distinguish fresh clots from organized clots and calcified tissue.

Enhance procedural planning with real-time data.

Improve PAD treatment outcomes by tailoring interventions to the type of obstruction.

Sensome’s CEO, Franz Bozsak, emphasized that their device represents a milestone in minimally invasive procedures. He highlighted the technology’s potential to overcome limitations of existing imaging techniques, ultimately improving patient outcomes and procedural efficiency.

Why Is Fresh Clot Identification Crucial in Peripheral Artery Disease?

Clots in PAD patients can vary significantly in composition. Fresh clots, rich in RBCs, require a different treatment approach compared to older, organized clots or plaque buildup. Currently, identifying fresh clots requires significant expertise and often remains inconclusive until after the procedure.

Professor Yann Gouëffic of Groupe Hospitalier Paris Saint-Joseph explained that a fresh clot’s composition impacts decisions on whether to aspirate, dissolve, or use other methods. The Clotild guidewire provides clinicians with actionable data in real time, addressing this critical knowledge gap.

The Broader Potential of Sensome’s Technology

Although initially focused on peripheral artery disease, Sensome’s technology is also being studied for other applications, including ischemic stroke and lung cancer. The company aims to integrate its clot-sensing guidewire system into various minimally invasive devices, enabling precise tissue analysis across specialties.

Sensome’s commitment to innovation has earned the Clotild Smart Guidewire Breakthrough Device Designation from the FDA. While the device is still investigational and not yet commercially available, Sensome has partnered with ASAHI INTECC, a global leader in guidewire manufacturing, to develop scalable solutions for clinical use.

Transforming the Future of PAD Treatment

As peripheral artery disease continues to affect millions worldwide, solutions like the Clotild guidewire could redefine how the condition is managed. By providing reliable, real-time insights into clot composition, Sensome’s technology empowers clinicians to make informed decisions, enhancing procedural success and long-term patient outcomes.

With its ability to deliver precise intra-operative tissue analysis, the Clotild Smart Guidewire is poised to become a cornerstone of modern vascular care, addressing unmet needs in peripheral artery disease and beyond.