Peripheral artery disease (PAD) affects over 200 million patients globally and is a significant health concern due to the systemic atherosclerotic disease it presents, especially regarding blood vessel blockages. Now, a breakthrough tissue microsensor technology could benefit millions of patients with PAD by improving long-term outcomes.

Sensome (Massy, France) has pioneered the connected medical device revolution with the world’s smallest biological tissue sensor. It has developed a breakthrough sensor technology that converts invasive medical devices into connected healthcare devices. The company’s innovative sensor technology, which combines micro-sensors based on impedance with advanced machine learning algorithms, can instantly identify various biological tissues with remarkable accuracy upon contact. Initially applied in the Clotild connected guidewire for ischemic stroke treatment, this technology was recognized as a breakthrough medical device by the FDA in 2021 for use in brain arteries.

In addition to its initial application, Sensome's technology has broader implications in fields like interventional cardiology and oncology. Currently, Sensome is undertaking the SEPARATE clinical trial, focusing on the use of the Clotild Smart Guidewire for PAD. This study aims to evaluate the sensor's effectiveness in identifying different types of blood vessel blockages in PAD patients. Specifically, the trial is centered on the sensor's ability to differentiate between soft, friable 'fresh' clots and more organized 'old' clots. Such differentiation is crucial for physicians to determine the most effective endovascular treatment strategies, ultimately reducing complications, preventing embolization, and improving the overall success of treatments.

“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,” said Dr. Koen Deloose, principal investigator of the SEPARATE clinical trial. “Sensome’s tissue microsensor technology could become a novel tool to characterize the total occlusion in an objective and simple-to-use way that integrates perfectly with our current existing workflow.”

“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,” added Franz Bozsak, CEO and co-founder of Sensome. 

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