A disruptive medical device to enable proton therapy as non-invasive and automated treatment of heart arrhythmias

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Heart arrhythmia is a major worldwide public health problem, accounting for 15–20% of all deaths. Heart arrhythmias affects over 15 million people in Europe and North America and this number is expected to double in the next 50 years due to the aging population and lifestyle changes. Catheter ablation is the current gold standard for heart arrhythmia treatment. The surgical procedure is performed by introducing a catheter under anaesthesia into the heart chambers, to ablate selected target regions by applying heat. This invasive procedure requires patient hospitalization, a staff of 10 doctors, and has a high risk of complications, such as bleeding, infection and damage to heart valves and blood vessels. EBAMed developed Cardio-kit, a non-invasive medical device for heart arrhythmia treatment using proton therapy. Cardio-kit is a plug & play system that can be integrated into any existing proton therapy machine. Cardio-kit enables monitoring of heart movements in real-time, and automatically adjust the Stop/Go signal to the proton therapy machine based on the cardiac cycle in which to intervene. Cardio-kit ensures an accurate, effective and safe treatment of the moving target within the heart at the right time. In this way, Cardio-kit facilitates an out-patient procedure, as it does not require any hospitalization or sedation. The procedure is quick, safe, painless and suitable for any age and health condition patient with no side-effects. The EIC funding will enable EBAMed to optimize the Cardio-kit hardware and software components, and to perform all the clinical validation activities necessary to obtain CE Mark and start commercialization in Europe.