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

Project Information

StentGuard

Grant agreement ID: 190107486

DOI

10.3030/190107486

Project closed

EC signature date 21 October 2022

Start date 1 October 2022

End date 31 July 2025

Funded under

• The European Innovation Council (EIC)

Total cost

€ 11 306 517,50

EU contribution

€ 2 500 000,00

Coordinated by

VESSELSENS GMBH
Germany

Periodic Reporting for period 3 - StentGuard (Clinical validation of the First Implantable Sensor System for Wireless detection of stent occlusion/ restenosis)

Reporting period: 2024-04-01 to 2025-07-31

Summary of the context and overall objectives of the project

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 an innovative German MedTech startup in the area of angiology and sensor technology and we develop the StentGuard, a smart therapeutic monitoring device that enables rapid, low cost and early diagnosis of in-stent restenosis non-invasively and reliably. Thereby also significantly reducing the number of amputations.

The ‘StentGuard’ 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 global economy billions of dollars per year.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Since the start of the action in October 2022, we have successfully completed tasks 1.1 1.2. are on track with task 1.3 given the ISO 10993-1:2018 requirements and are waiting for approval to start task 1.4

In detail,

For task 1.1 (StentGuard Geometry and Signal Optimisation) we have successfully
• determined the optimum geometric configuration of the StentGuard through mechanical, electrical and usability testing.
• maximized the signal capture of the read-out unit (ROU) and increasing the signal to noise ratio by designing the electronics for electromagnetic compatibility and applying digital filters.
• developed the final design of the delivery system.

With regard to task 1.2 (Software Optimisation), we have successfully
• optimised the algorithm for diagnostic support to improve the accuracy and speed of the calculation using the NASCET criteria.
• Tested the algorithm to be provided as an approved and compiled library (e.g. DLL) to be integrated into the cloud-based web-service.

With regard to task 1.3 (Biological safety evaluation), we have successfully
• carried out and met the requirements of the relevant tests according to ISO 10993-1:2018 that are to be carried out before the animal testing


With regard to task 1.4 (Animal Testing), we have successfully
• Submitted our application to the ethical committee end of 2023 and are currently waiting to obtain the approval to start with the planned animal testing.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

In order to make our solution available to the world and help people to not lose their limbs or even die due to Critical Limb Ischemia (CLI), while our solution will help reduce this, we still require a lot of capital to push our solution through the regulatory process. Apart from the necessary capital, which will be the basis to move forward, we will require support in the academic world as well as the industry.

StentGuard