Feasibility phase

Atrial fibrillation is the most common cardiac arrhythmia and causes one in four strokes. The cause is a small cavity in the heart (the left atrial appendage) where most blood clots form and can subsequently travel to the brain. Preventive measures are either blood-thinning medication or closure of the left atrial appendage. However, existing closure implants are in great need of improvement, as they often do not seal tightly, leading to further clot formation.

Advancing Implant Technology to Reduce Stroke Risk

The SIC-2 project aims to develop an implant that allows optimal closure of the atrial appendage through adjustable size. This also includes the first sensor-controlled implantation of this type to detect and eliminate leaks. The leak detection technology is based on a sensor-equipped implant cover and can also be used in other areas of implantable medical devices, such as heart valve replacements and vascular prostheses.
In this project, experts from Hereon and Charité are advancing the technology in advanced in-vitro and in-vivo tests to bring it closer to clinical application. Ultimately, the project aims to significantly improve the treatment and, therefore, the quality of life of patients at risk of stroke.

Conceptual phase

Strokes triggered by atrial fibrillation are often caused by changes in blood flow velocities (turbulent flow) in the left atrium and especially in the left atrial appendage. As the left atrial appendage could be identified as the site of origin for the responsible blood clot in more than 90% of strokes, an occlusion of this small heart cavity has established itself as a possible treatment option in recent years. The closure is minimally invasive. By means of a catheter, a shield (so-called occluder) is inserted into the atrial appendage. Due to existing technical limitations of the current occluder systems, there are still risks such as leaks or impairment of blood flow by the occluder. Similar problems can occur with other catheter procedures where an implant must be inserted precisely and purposefully. The problem in daily practice arises from the fact that the imaging techniques used to monitor the position are often not precise enough. The aim of this project is therefore to test exploitation options for a sensor-controlled implantation technology that enables direct feedback from the implant about its position generated in real time. Impedance sensors on the implant are intended to indicate tissue contact or contact strength in order to achieve optimal anchorage without tissue damage and leakage. This would significantly improve both the efficiency and safety of the procedures. In the exploratory phase an IP strategy will be developed, the market and competition will be analysed and an implementation plan for the subsequent feasibility phase will be drawn up.

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