Results Presented in Europe for Theraclion's Echopulse to Treat Varicose Veins

October 16, 2018—Theraclion announced the presentation of preliminary results from the clinical trial of the company's Echopulse echotherapy system as a treatment for varicose vein of the lower limbs. The study aims to assess echotherapy for this new indication in terms of feasibility, efficacy, and tolerability. Alfred Obermayer, MD, presented the findings at the Congress of the German Society of Phlebology held September 26–29 in Bielefeld, Germany. Dr. Obermayer serves as Principal Investigator of the trial and is a surgeon at St. Joseph Hospital in Vienna, Austria.

According to the company, the noninvasive echotherapy treats tortuous structures, severe trophic cases, and reoccurrences with an image-guided robotic device. Theraclion plans to submit applications for the device for both CE Mark and FDA approval for this indication by the end of 2018.

The 3-month follow-up data were presented from cases targeting greater saphenous veins, accessory saphenous veins, perforator veins, recurrences (after surgery, foam therapy, and endovenous methods) and refluxing stumps. The cases were feasible, and no adjunctive methods of any kind were used during the study. No significant side effects were observed, and no antithrombotic or anticoagulant drugs were administered.

In Theraclion's announcement, Dr. Obermayer commented, “This new technique is the first noninvasive approach in the veins domain. Heat deposited for occluding an insufficient vein is transmitted percutaneously via high intensity focused ultrasound. This means: no incision, no sterile field needed, and the possibility to treat severe conditions such as ulcers. The precision of the heat deposition allows treatment of very tortuous structures or recurrences that are difficult to treat surgically. Taking into consideration my past experience with surgery, radiofrequency, laser, and foam sclerotherapy approaches in this indication, I am extremely impressed by this new treatment approach which is globally very promising.”