VEINRESET Pivotal Trial Evaluates Theraclion’s Sonovein for HIFU Varicose Vein Treatment

September 15, 2025—Theraclion, the France-based developer of the Sonovein platform for noninvasive high-intensity focused ultrasound (HIFU) varicose vein treatment using robotic technology, announced the top-line results from its VEINRESET United States pivotal trial.

According to the company, the single-arm, prospective, multicenter clinical trial was conducted to assess the safety and efficacy of the Sonovein device in treating primary insufficiency of the great saphenous vein (GSV).

As summarized by Theraclion, the VEINRESET trial was composed of 70 patients enrolled at four centers in the United States (one in New York; one in New Jersey), Austria, and the Czech Republic. Steve Elias, MD, is Principal Investigator of the study.

According to the company, the trial met its primary endpoint, confirming efficacy with an occlusion rate of 96.8% at 12 months (95% CI, 88.3% to 99.2%) and confirming safety with no serious or unanticipated adverse events, and only one mild adverse event reported throughout the study.

Additionally, the secondary endpoints included a reflux abolition rate of 98.5%, pain disappeared in all patients, and symptoms were completely resolved in most patients measured by the Venous Clinical Severity Score.

None of the patients underwent complementary procedures. Both patients and investigators were satisfied with the device/procedure outcome, reported the company.

The study demonstrated that using HIFU generated by Sonovein is safe and effective for the treatment of symptomatic primary GSV insufficiency, concluded Theraclion.

“These results demonstrate that completely noninvasive HIFU with Sonovein is equal to state-of-art methods available now,” commented Dr. Elias in the company’s press release. “It is certainly a reliable and viable option equivalent to our traditional treatments with other patient benefits.”

Theraclion advised that the results will form the basis of its planned submission to the FDA for authorization to access the United States market, where Sonovein is currently limited to investigational use. The Sonovein HIFU platform has received a European CE Mark approval for varicose vein treatment.