Health Problem: Varicose veins are dilated, thickened, elongated, and twisted blood vessels that may appear thread-like or as grape-like clusters under the skin, most often on the legs. They are manifestations of chronic venous insufficiency, a condition characterized by dysfunction of the valves in veins leading to increased blood pressure, blood pooling, and venous reflux in affected areas. Varicose veins may be asymptomatic, or the associated venous insufficiency may cause heaviness, fatigue, aching, burning, throbbing, numbness, cramping, swelling, itching, rash, discoloration, and ulceration of the affected limb. In addition, risk is increased for thrombophlebitis, deep vein thrombosis, and pulmonary embolism.

Technology Description: The VenaSeal Closure System is approved for the permanent closure of lower extremity superficial truncal veins through endovascular cyanoacrylate embolization with coaptation in adults with clinically symptomatic venous reflux as diagnosed by duplex ultrasound. The medical device is a sterile, single-patient kit comprising the VenaSeal adhesive (cyanoacrylate) and VenaSeal delivery system components. The cyanoacrylate adhesive is placed in the vein via a small catheter. Once inside the vessel, the cyanoacrylate adhesive polymerizes into a solid material upon contact with body fluids or tissue. This acute coaptation results in the termination of blood flow through the insufficient target vein. Pressure is then applied to the leg to help seal the vein. The implanted adhesive becomes fibrotically encapsulated to establish a durable, chronic occlusion of the treated vein. The catheter is then removed from the vein and a bandage is placed over the insertion wound.

Controversy: Traditionally, vein stripping has been used to treat varicose veins. Alternative methods have been sought as stripping requires general or spinal anesthesia; increases risk for saphenous nerve injury; may result in substantial postoperative pain, hematoma, and recovery time; and is associated with a high recurrence rate. Ablation techniques generally lead to better cosmetic outcomes, less pain, and shorter recovery periods than surgery. Endovascular thermal ablation has largely replaced stripping for treating larger and deeper veins; however, thermal ablation requires tumescent anesthesia and specialized equipment and training, increases risk of damage to normal adjacent tissue, and is associated with relatively common recurrence. The use of non-thermal, non-tumescent endovenous techniques, such as coaptation with a cyanoacrylate adhesive, is thought to improve patients’ perioperative experiences as it does not require tumescent anesthesia or compression stockings. However, controversy surrounds the comparative effectiveness of this system with other endovenous techniques and whether long-term effects are sustained after treatment.

Key Questions:

  • Is cyanoacrylate embolization with the VenaSeal Closure System effective in treating symptomatic venous reflux?

  • How does cyanoacrylate embolization with the VenaSeal Closure System compare with alternative treatments for symptomatic venous reflux?

  • Is cyanoacrylate embolization with the VenaSeal Closure System safe?

  • Have definitive patient selection criteria been identified for cyanoacrylate embolization with the VenaSeal Closure System for the treatment of symptomatic venous reflux?

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