Safety assessment of an implant for clinical research and cardiology

Symptoms of heart failure are often attributed to advancing age and are thus not taken seriously – but heart failure is a serious, life-threatening condition. A particularly high mortality risk is associated with this condition in conjunction with diabetes: between 25 and 50 percent of these patients die within the following 3 to 5 years.


The development of healthcare solutions for people with heart failure is thus of pivotal importance. Only one in ten candidate drugs tested in phase-I clinical trials reach market maturity, at extremely high costs and after a lengthy trial period (up to 15 years). Approved drugs, however, often reveal a lower efficacy in daily healthcare routine than during the clinical trials, a phenomenon referred to as “efficacy-to-effectiveness gap.” The AI-powered exploitation of real-world data – data collected in real-life clinical practice – is aimed at making a significant impact on the real-world effectiveness of treatments for heart failure patients and at the same time leveraging savings in the amount of billions of euros.

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For high-quality collection of real-life cardiorespiratory health data, Fraunhofer ITEM scientists and their project partners are developing a medical multi-sensor system that can be implanted subcutaneously. The aim is to achieve a substantial improvement in drug development and patient care through data collected in real-life clinical practice.

The RealWorld4Clinic project consortium comprises different European partners from commercial and academic research institutions and university-based maximum-care hospitals. It has been established to develop a medical multi-sensor system (MySentinel) that will enable high-quality collection of real-life cardiorespiratory health data. The class 3 medical device is implanted subcutaneously near the heart and lungs to measure a range of cardiorespiratory parameters. The recorded biomarkers allow conclusions to be drawn about the safety, tolerability and efficacy of an active ingredient under everyday conditions. Another aim is that cardiologists receive data suggesting an aggravation of heart failure at an early stage. In this way, they could gain up to 30 days to initiate interventions that can prevent escalation up to acute hospitalization.

At Fraunhofer ITEM, scientists of the Division of Translational Biomedical Engineering collaborated with colleagues from several other departments of the institute, with external service providers and with the manufacturer of this device to perform assessment and biocompatibility testing for the intended use and position, as required for regulatory approval, within the ISO 13485-certified quality management system. Beyond the mere regulatory requirements of ISO 10933, the researchers performed further studies in a multi-endpoint process to collect additional data on the safety of the active implant when applied in humans, as well as to reduce the manufacturer's commercial risk. Further on in this collaboration, first clinical trials for functionality testing of the implant are planned to be conducted.



Ulrich Froriep

Contact Press / Media

Dr. Ulrich Froriep

Deputy Division Director of Translational Biomedical Engineering

Phone +49 511 5350-294