Focused Ultrasound Therapy

Outside Approval SquareFocused ultrasound is an early-stage, non-invasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with varicose veins. This novel technology focuses beams of ultrasound energy precisely and accurately on targets in the body without damaging surrounding normal tissue. Where the beams converge, the ultrasound produces precise ablation (thermal destruction of tissue) enabling varicose veins to be treated without surgery.

The primary options for treatment of varicose veins are surgery, sclerotherapy, intravenous laser therapy, or radio frequency closure techniques.

For certain patients, focused ultrasound could provide a non-invasive alternative to these techniques with less risk of neurologic problems, phlebitis, wound issues, or other complications.

Clinical Trials SquareAdvantages of focused ultrasound:

  • A non-invasive approach that requires no intravenous catheters, surgery or anesthesia.
  • No risk of neurologic damage from sclerotic drugs.
  • The therapy can be repeated as needed.

Clinical Trials

A clinical trial in Austria has been completed. It explored using Theraclion's Echopulse device to noninvasively treat superficial and perforating varicose veins in the lower extremity. A publication is expected soon. 

Regulatory Approval and Reimbursement

Theraclion has achieved the CE Mark in Europe for its SONOVEIN® system after successful clinical trials.

Focused ultrasound treatment for varicose veins is not yet approved by regulatory bodies in the US or covered by medical insurance companies.

Notable Papers

Barnat N, Grisey A, Lecuelle B, Anquez J, Gerold B, Yon S, Aubry JF. Noninvasive vascular occlusion with HIFU for venous insufficiency treatment: preclinical feasibility experience in rabbits. Phys Med Biol. 2019 Jan 7;64(2):025003. doi: 10.1088/1361-6560/aaf58d.

Kim MS, Kim JY, Noh SC, Choi HH. Thermal characteristics of non-biological vessel phantoms for treatment of varicose veins using high-intensity focused ultrasound. PLoS One. 2017 Apr 6;12(4):e0174922. doi: 10.1371/journal.pone.0174922. eCollection 2017.

Petrishchev NN, Semenov DU, Tsibin AU, Yukina GU, Berkovich AE, Bursian AA, Belyankin AB, Senchik KU. Effekt of blood flow shutdown on the vein damage when exposed to HIFU. Patol Fiziol Eksp Ter. 2017 Apr-Jun;61(2):46-50. Russian.

Henderson PW, Lewis GK, Shaikh N, Sohn A, Weinstein AL, Olbricht WL, Spector JA. A portable high-intensity focused ultrasound device for noninvasive venous ablation. J Vasc Surg. 2010 Mar;51(3):707-11. doi: 10.1016/j.jvs.2009.10.049. Epub 2010 Jan 4.

Click here for additional references from PubMed.

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