Home Diseases and Conditions Varicose Veins

Varicose Veins

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Development Stage

Early Stage

Focused ultrasound research is in the laboratory phase and is not yet available for patients.

Clinical Trials

Focused ultrasound for this condition is being researched in clinical trials.

International Approval

Focused ultrasound is approved to treat this condition outside the US. Patients can seek commercial treatment at participating international sites.

FDA Approved

The US Food and Drug Administration has approved focus ultrasound for this condition. Patients can seek commercial treatment at participating sites.

Early Stage

Clinical Trials

International

FDA Approved

Focused ultrasound is approved to treat this condition outside the US. Patients can seek commercial treatment at participating international sites. There are also clinical trials that may be of interest to patients.

Focused Ultrasound Therapy

Focused ultrasound is a noninvasive, 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.

How it Works
Where the beams converge, the focused ultrasound produces precise ablation (thermal destruction) of the varicose vein. This enables varicose veins to be treated noninvasively.

Advantages
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 noninvasive alternative to these techniques with less risk of neurologic problems, phlebitis, wound issues, or other complications. It also requires no intravenous catheters, surgery, or anesthesia and can be repeated as needed.

Clinical Trials

A clinical trial using the Sonoblate High Intensity Focused Ultrasound system is recruiting patients with chronic venous incompetence for treatment.

A multi-site clinical trial testing the Sonovein system for treatment of greater saphenous vein disease has been completed. 

The Foundation updates these pages regularly, but with the increasing number of clinical trials, we want to be sure that our audience has the latest information available. Therefore, we also added the website search information for the above trials. If you click here, it will take you to the latest information available from https://www.clinicaltrials.gov/. 

Regulatory Approval and Reimbursement

Theraclion’s Echopulse 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

Casoni P, Bissacco D, Pizzamiglio M, Nanni E. High intensity focused ultrasound in treating great saphenous vein incompetence: Perioperative and 1-year outcomes. Phlebology. 2024 Apr 1:2683555241243161. doi: 10.1177/02683555241243161. PMID: 38560785 

Obermayer A, Aubry JF, Barnat N. Extracorporeal Treatment with High Intensity Focused Ultrasound of an Incompetent Perforating Vein in a Patient with Active Venous Ulcers. EJVES Vasc Forum. 2020 Dec 5;50:1-5. doi: 10.1016/j.ejvsvf.2020.11.005. eCollection 2021.

Barnat N, Grisey A, Gerold B, Yon S, Anquez J, Aubry JF. Vein wall shrinkage induced by thermal coagulation with high-intensity-focused ultrasound: numerical modeling and in vivo experiments in sheep. Int J Hyperthermia. 2020;37(1):1238-1247. doi: 10.1080/02656736.2020.1834626.

Whiteley MS. High intensity focused ultrasound (HIFU) for the treatment of varicose veins and venous leg ulcers – a new non-invasive procedure and a potentially disruptive technology. Curr Med Res Opin. 2019 Dec 6:1-4. doi: 10.1080/03007995.2019.1699518.

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.

Click here for additional references from PubMed.