FDA granted Theraclion a De Novo marketing authorization for Sonovein on November 4. The platform coagulates great saphenous vein segments in patients with superficial vein reflux. Theraclion says it is the first focused ultrasound system authorized in the US for varicose veins, and the decision creates a new device classification.
The authorization rests on VEINRESET (NCT05926830), a 70-patient study run at four centers in the US and Europe. The primary endpoint was met with a 96.8 percent occlusion rate at 12 months. Theraclion reported one mild adverse event and no serious or unanticipated events. Sonovein delivers energy through the skin, with no incision and no intravascular catheter.
A Category III CPT code for the procedure took effect October 1, 2026. Theraclion has incorporated a US subsidiary, Sonovein Inc., and plans to start with reference treatment centers built around physician training and service support. The company runs from Malakoff, outside Paris, with about 40 staff, and trades on Euronext Growth Paris as ALTHE.
The CPT code arriving a month before the authorization is the detail to copy. It gives the procedure somewhere to be reported while Theraclion collects the utilization data commercial payers ask for before they write a coverage policy.