Theraclion has announced that Alfred Obermayer, principal investigator of the varicose vein treatment clinical trial in Austria, presented preliminary results at the Congress of the German Society of Phlebology in Bielefeld, attended by around 1,200 participants. The study aims to assess echotherapy for this new indication in terms of feasibility, efficacy, and tolerability.
“With around 500 000 vein procedures (stripping, endovenous, and scerotherapy) performed annually, Germany is the biggest market in Europe. It also is the market where endovenous procedures are the most penetrated and covered by the health insurance companies,” says Anja Kleber, vice president Marketing & Market Access. “This is why Echopulse’s first scientific varicose vein treatment presentation was unveiled in Germany.”
Three-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, 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.
“This new technique is the first non-invasive approach in the veins domain. Heat deposited for occluding an insufficient vein is transmitted percutaneously via high intensity focused ultrasound (HIFU). 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,” says Alfred Obermayer, principal investigator and surgeon at St Joseph Hospital in Vienna. “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.”
“We are very satisfied with these early results in the first ever human study on veins with HIFU,“ says Michel Nuta, vice president, Veins, Theraclion. “This is the next era in the therapeutic domain for veins. Some spectacular results were observed in patients with a long medical history and poor results with previous treatments using other methods. The trial confirmed that our experience very accurately deposits heat in thousands of thyroid and breast fibroadenoma patients is reproducible in veins.”
“This is the first podium presentation in one of Europe’s largest vascular veins congress and the first after completing our registration study. Feedback from Dr Obermayer and his peers throughout the world make us confident that our technology will revolutionise the treatment of varicose veins. The non-invasive capability of echotherapy to treat tortuous structures, treat severe trophic cases and reoccurrences with an image-guided robotic device is a quantum leap forward compared to current therapeutic offerings. We aim to submit a dossier for both CE marking and FDA approval by the end of 2018. We will then aim at proposing this solution to key sites in Germany as this is our European showcase for thyroid and breast today,” says David Caumartin, CEO of Theraclion.