Clinical validation of the First Implantable Sensor System for Wireless detection of stent occlusion/ restenosis

Globally, over 237 million people suffer from peripheral artery disease (PAD), an abnormal narrowing of the arteries. The implantation of stents (spiral wire protheses) is the first-line therapy for PAD with ~ 3.5M stents implanted worldwide every year. Restenosis, the gradual reclogging of the blood vessel after stent implantation, is a major problem leading to high morbidity and mortality which occurs within 6 years after implantation in ~23 % of all cases and is often detected when it is too late. More frequent surveillance of PAD patients to avoid unnecessary amputations and death is an unmet clinical challenge. VesselSens is developing the StentGuard, a smart therapeutic monitoring device that enables rapid, low cost, early diagnosis of restenosis non-invasively and reliably. This device allows stent monitoring at high frequencies with low cost by non-specialist medical practitioners solving the problem of unchecked disease progression and saving the EU economy over €1bn/ year.