Photo: Ivan Babydov / Pexels, Pexels License (cropped and resized). Generic examination room, not the Sonovein device or a Theraclion treatment center.
French medical-device maker Theraclion says it has cleared a major hurdle to selling its non-invasive vein-treatment system in the United States. The next test is commercial: training physicians, opening treatment centers and building a path to payment.
The company said Thursday that the Food and Drug Administration granted De Novo marketing authorization to Sonovein on November 4. The system uses high-intensity focused ultrasound delivered through the skin to treat superficial venous reflux in segments of the great saphenous vein, without an incision or a catheter inside the vein.
The authorization and clinical results were described in Theraclion’s November 5 announcement. They are company-reported; the announcement is not evidence that the treatment is already widely available or covered by U.S. insurers.
A U.S. launch, not an instant national rollout
Theraclion said its U.S. subsidiary, Sonovein Inc., has been established and launch preparations are in place. It plans to begin with reference treatment centers supported by physician training, clinical onboarding and technical service, then broaden adoption.
A dedicated Category III CPT code became active October 1, according to the company. Theraclion described that as an initial step toward developing coverage and payment pathways. A reporting code is not the same as an insurer agreeing to pay for a procedure.
What the study measured
The company said its VEINRESET pivotal study involved 70 patients at four U.S. and European centers and reported a 96.8% great saphenous vein occlusion rate at 12 months. Occlusion means closure of the targeted vein; that figure should not be read as a cure rate for every symptom or every patient with varicose veins.
Theraclion reported no serious or unanticipated adverse events and one mild adverse event in that study. A study of that size cannot establish that a procedure has no risks. Treatment suitability and risks require assessment by a qualified clinician.
Why the business milestone matters
The U.S. authorization removes a regulatory barrier for a company seeking to expand a device already used outside the country. Theraclion said Sonovein has been adopted by more than 20 centers worldwide and used in more than 4,000 procedures.
That gives the launch an existing operating base, but not a guaranteed U.S. revenue stream. Placement of equipment, physician use and payment arrangements still have to turn regulatory access into sustained business. The release did not give a U.S. patient price or a nationwide availability date.
JBizNews Desk | Paris
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