Clinical studies are under way to test an innovative catheter that can accurately and safely heal unhealthy heart tissue through single, shorter energy pulses, with developers hoping that approval will be followed by launch in 2028, reports Euronews.
The technological breakthrough has been designed, manufactured and tested in the European Union, where around 10% of the population aged 60 and above is reported to suffer from heart arrhythmia.
“Clinical perception of the condition is highly variable,” said Petr Neužil, head of the Cardiology Clinic at Na Homolce Hospital, one of Czechia’s main hospitals. “The patient may perceive nothing; they may be completely asymptomatic. Then, they can feel palpitations. They can feel breathless. They cannot breathe. And very often they feel weakness.”
Doctors here treat the condition through ablations made with the flexible tubes commonly known as catheters. These are placed into blood vessels and guided to the heart.
They use heat or cold energy to create tiny scars on the surface of the heart. These scars help break up or insulate the electrical signals that cause irregular heartbeats.
Czech hospitals have the capacity to treat only 10 000 patients each year – around one quarter of those in need. Waiting lists can stretch for up to 10 months, which is partly why this hospital is taking part in the clinical study of this innovative catheter.
The solution would safely hasten the process, improve patient recovery time, decrease waiting lists and reduce operational costs.
“You spend less time with the catheter. You have a single shot. You lessen the applications, you lessen the manipulations and you lessen the tools you need to get inside,” said Neužil.
The catheter has been developed by BTL Industries, a family company that has become a global powerhouse for healthcare devices, its hi-tech medical products being exported to 80 countries. The new catheter and its control unit have been designed to make the ablation procedure faster and more accurate.
“The doctor places the catheter in the vein and ablates, with a single shot for the whole area all at once, as he needs it. So the time saved ranges from three hours to 15 minutes for ablation,” said Martin Hanuliak, the company’s Head of Product Management.
“The procedure is safer because we apply microsecond – that is one millionth-of-a-second – pulses, which ideally destroy the myocardium and spare the other tissue, so the heart heals faster and better.”
“The main difference between the catheter that we are developing and standard catheters is that ours is much more complex,” said Jiří Dašek, product manager at the company. “It contains very small parts that are less than one millimetre in size. The second difference is that our catheter moves – in the past, the only catheters used were straight and fixed, without any moving parts.”
Once approved by the health authorities, it is planned for the new catheter and its control unit to also be entirely made in the European Union. One million electronic boards are produced every year at the company’s manufacturing facilities. These parts are then assembled in around 40 000 different medical devices.
Doctors and developers hope that it will be available on EU markets from the beginning of 2028.
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