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

Introduction

Globally, over 237 million people suffer from peripheral artery disease (PAD), an abnormal narrowing of the arteries. The implantation of stents (spiral wire prostheses) is the first-line therapy for PAD, with approximately 3.5 million stents implanted worldwide every year.

Problem Statement

Restenosis, the gradual reclogging of the blood vessel after stent implantation, is a major problem leading to high morbidity and mortality. This condition occurs within 6 years after implantation in about 23% of all cases and is often detected when it is too late.

Clinical Challenge

More frequent surveillance of PAD patients is necessary to avoid unnecessary amputations and death, which represents an unmet clinical challenge.

Solution

VesselSens is developing the StentGuard, a smart therapeutic monitoring device that enables:

• Rapid, low-cost, early diagnosis of restenosis
• Non-invasive and reliable monitoring

This device allows stent monitoring at high frequencies with low cost by non-specialist medical practitioners, addressing the problem of unchecked disease progression and potentially saving the EU economy over €1 billion per year.