A Novel, Simple, and Secure, Percutaneous Vessel Occluder for the Treatment of Varicose Veins

BACKGROUND: Secure, permanent occlusion of the saphenous vein, its tributaries, and perforators, is critical for the successful treatment of varicose veins. Current minimally invasive methods replacing surgery are all endoluminal, involving heat (radio-frequency or laser) and/or chemicals (sclerosants and glues).

The objective of this study was to evaluate, in a porcine model, the performance of a percutaneous ultrasound guided delivery of the Amsel™ Vessel Occluder (AVO).

METHODS: The AVO, a novel mechanical occlusion clip similar to a transfixion suture, is delivered through an 18G hypodermic needle, which transfixes and occludes the targeted vessel. Selected vessels were occluded under duplex ultrasound (DUS) guidance. Tissue response (healing) to open vs percutaneous vessel occlusion vs standard vessel access with sheath insertion, was compared by histology at 7 and 30 days.

Results: 42 percutaneous vessel occlusions (vessel sizes 1.8mm-12.7mm) were successfully performed in the femoral vessels, carotid arteries and jugular veins. Tissue response was less for percutaneous (N=6) than open surgical vessel occlusion (N=6), and more similar to the vessel access procedure (N=6).

Conclusions: This study confirms that the AVO can be effectively and safely delivered percutaneously to occlude blood vessels under DUS guidance. It provides a permanent, secure, mechanical vessel occlusion, similar to a transfixion suture, eliminating recanalization which occurs with thermal or chemical vessel occlusion methods. The AVO may be a useful, time-saving, cost-effective adjunct to current methods of treating reflux in the saphenous vein, its tributaries or perforators, for the treatment of symptomatic varicose veins, providing, in addition, a simple alternative in the event of other treatment method failures.