The short version
- The FDA has authorized Sonovein, a device that closes a faulty leg vein by focusing ultrasound on it from outside the skin, with no incision or catheter.
- In the company’s 70-patient trial, 96.8% of treated great saphenous veins were still closed a year later, with no serious adverse events reported.
- The trial had no comparison group and its results are not yet published or posted, so how it stacks up against today’s catheter treatments is unknown.
The US Food and Drug Administration granted De Novo marketing authorization on November 4 to Sonovein, a high-intensity focused ultrasound device from the French company Theraclion. It is cleared to seal off the great saphenous vein, the long vein up the inside of the leg whose leaky valves are the main cause of varicose veins. The ultrasound is focused on the vein from outside the body, so there is no incision and no catheter inside the vein. De Novo is the route for new low-to-moderate-risk devices with nothing comparable already on the market.
The evidence is the VEINRESET trial, which treated 70 patients at two US centers in New Jersey and New York and two in Austria and the Czech Republic. According to Theraclion, 96.8% of treated veins were closed at 12 months, with no serious adverse events and one mild one. Every patient got the device, and there was no comparison group treated another way. The registry entry lists the trial as completed in June 2025 with no results posted, and no paper has appeared. The numbers are the company’s.
The device is already CE-marked in Europe, where the company says it has been used in more than 4,000 procedures.
