Focus of the Report: The focus of this Health Technology Assessment (HTA) is to evaluate the safety and effectiveness of cyanoacrylate embolization (CAE) with the VenaSeal closure system (Medtronic Inc.) to treat symptomatic varicose veins. This HTA also compares the effectiveness and safety of the VenaSeal closure system with other endovenous treatments and surgical vein stripping.
Technology Description: The VenaSeal closure system is approved for the permanent closure of lower extremity superficial truncal veins through nonthermal endovascular CAE with coaptation in adults with clinically symptomatic venous reflux as diagnosed by duplex ultrasound. CAE is performed in an outpatient setting and provides a nonthermal, endovenous technique that does not require tumescent anesthesia or compression stockings or wraps following treatment and allows for reduced procedural time, quicker recovery time after treatment, and reduced likelihood of nerve damage and hematoma.
Controversy: The use of nonthermal nontumescent 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 or wraps following treatment. However, controversy surrounds the comparative effectiveness of this system with other endovenous techniques and whether long-term effects are sustained after treatment.
Key Questions:
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Is CAE with the VenaSeal closure system effective for treating symptomatic varicose veins in adults with venous reflux disease?
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How does CAE with the VenaSeal closure system compare with endovenous thermal ablation, sclerotherapy, mechanochemical ablation (MOCA), coil embolization, and surgery for the treatment of symptomatic varicose veins in adults?
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Is CAE with the VenaSeal closure system for treating symptomatic varicose veins in adults safe?
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Have definitive patient selection criteria been identified for CAE with the VenaSeal closure system for treating symptomatic varicose veins?
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