Varicose veins without needles, catheter or heat: new method successfully tested on first patients

In Europe, the first human trials have begun for a new way to treat varicose veins without puncturing the vessel, using a catheter, or heating tissue. The first four patients have already undergone the procedures, and a week later doctors recorded closure of the treated vein segments. However, the study has only just begun, so it is too early to talk about proven effectiveness and safety of the method.

This concerns the EASY-VEIN NT study by the French company Veinsound. It is testing a non-invasive system that acts on the diseased vein from outside using high-intensity focused ultrasound (HIFU) and uses artificial intelligence (AI) for navigation and procedure control.

How the new method differs from standard varicose vein treatment

Today, endovascular methods are often used to close pathologically dilated veins. A catheter is inserted into the vein, through which laser or radiofrequency energy acts, or special medications or medical glue are applied.

The new system works differently. The doctor places an ultrasound probe on the skin, and the energy is focused on a specific segment of the vein inside the body.

In doing so, the developers are trying to avoid not only the catheter but also heating of the vessel.

Instead of thermal effect, cavitation is used — a mechanical effect in which ultrasound causes the formation and rapid collapse of microscopic bubbles. This acts on the vein wall and should lead to its closure.

Why the system needs artificial intelligence

AI algorithms help the system find the target vein, track its position, and control ultrasound exposure parameters in real time.

The artificial intelligence itself does not treat the patient. It is used as an auxiliary tool for navigation and more precise procedure delivery.

What happened with the first patients

By mid-September, the procedure had been performed on the first four study participants.

According to the developer, the first interventions on the great saphenous vein took less than 12 minutes and were carried out without anesthesia.

A week after the procedure, researchers observed closure of the treated vein segment and changes in its wall.

However, this involves only the very first patients and a very short follow-up period. These data do not yet allow us to understand how often the method will work, whether the vein closure will persist after months or years, and what complications may appear later.

Why avoiding heat may be important

In laser and radiofrequency ablation, energy heats the inner wall of the vein. To reduce pain and protect surrounding tissues, a special solution for local anesthesia is often injected around the vessel.

If mechanical focused ultrasound confirms its effectiveness, the procedure could potentially avoid intravascular catheter, punctures, and thermal exposure in the future.

But for now, this is exactly a hypothesis that needs to be confirmed in a full clinical study.

Focused ultrasound itself has been studied before

The use of focused ultrasound to close superficial veins is not a completely new idea.

In previous studies, the thermal variant of the technology was predominantly used: focused energy heated a segment of the vessel and led to its closure.

The difference of the new approach is that researchers are trying to achieve the same result by mechanical effect — without significant tissue heating.

Before moving to human testing, this principle was tested in preclinical experiments, where mechanical focused ultrasound was able to stop blood flow in a small vein.

When it will become clear whether the method actually works

Completion of the EASY-VEIN NT study is expected in the first quarter of 2027.

Before then, developers will need to assess not only immediate vein closure, but also the safety of the procedure, durability of the result, and possible side effects.

The device remains experimental. It has not entered widespread medical practice and does not have European approval for commercial use or approval from the U.S. Food and Drug Administration.

Therefore, this is not about a new available method of treating varicose veins, but about the first testing in humans of a technology that could potentially make closure of diseased veins completely non-invasive — without a catheter, vessel puncture, or tissue heating.

Source: ICH GCP, Veinsound, Ultrasound in Medicine & Biology.