Approximately one-fifth of adults have varicose veins of the lower extremities, and up to 60% may have chronic venous disease that predisposes them to varicosities. Recently developed techniques such as liquid or foam sclerotherapy, endovenous laser ablation (EVLA), and radiofrequency ablation (RFA) collapse and seal the vein, and are associated with better cosmetic outcomes and less pain. However, thermal methods may cause damage to adjacent nerves and other tissues, including skin burns and pigmentation, nerve damage, and formation of arteriovenous fistulas.

Description of Technology: This health technology assessment focuses on the use of endovenous mechanochemical ablation (MOCA) (ClariVein Infusion Catheter) for treatment of varicose veins. The device features a flexible, steerable infusion catheter with a 360° rotatable dispersion wire. The wire tip causes minimal mechanical damage to the endothelium, inducing vasospasm, and the rotating tip evenly distributes a sclerosing agent to the targeted treatment area. After treatment, sealing of the vein is confirmed ultrasonically. Sclerosis of the vein activates the clotting system, resulting in formation of a thrombus and occlusion of the vessel.

Patient Population: MOCA with the ClariVein Infusion Catheter is intended for the infusion of physician-specified agents in the peripheral vasculature. It is used in patients with varicose veins of the lower extremities.

Clinical Alternatives: Alternative treatments for varicose veins are lifestyle changes (weight loss, exercise, and elevation of the limb), compression therapy with bandaging or other products, surgical vein stripping, sclerotherapy, RFA, EVLA, steam ablation, and n-butyl cyanoacrylate glue.

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