Sensome has commenced the SEPARATE clinical trial to evaluate its Clotild Smart Guidewire technology in detecting blood vessel blockages in patients with peripheral artery disease (PAD).
The Clotild device, which received breakthrough designation from the US Food and Drug Administration (FDA) for brain artery applications in 2021, is now being tested for its potential benefits in PAD treatment.
The trial aims to determine the ability of the Clotild sensor to differentiate between various types of blood vessel blockages, including friable “fresh” clots and organised “old” clots.
This distinction is said to be crucial for physicians to tailor endovascular treatments effectively to help reduce complications, prevent embolisation, and improve long-term patient outcomes.
Sensome CEO and co-founder Franz Bozsak said: “After successfully applying our technology to the treatment of ischemic stroke patients, we are excited about the opportunity to build on this work to potentially help millions of patients around the world whose lives have been impacted by PAD.”
The first five subjects for the trial have been enrolled at AZ Sint-Blasius Hospital in Dendermonde, Belgium.
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Sensome anticipates preliminary results from the trial by mid-2024.
AZ Sint-Blasius Hospital vascular surgery head Dr Koen Deloose said: “Understanding the makeup of a total occlusion in peripheral artery disease is essential to choose an adequate treatment approach to ensure lower complication rates and more durable long-term outcomes in this complex group of vascular patients.
“Sensome’s tissue microsensor technology could become a novel tool to characterise the total occlusion in an objective and simple-to-use way that integrates perfectly with our current existing workflow.”