A new occlusion device: application of the ArtVentive endoluminal occlusion system (EOS)--first in human clinical trial.

Purpose: The purpose of this study was to determine the safety and efficacy of a new endoluminal occlusion device, ArtVentive endoluminal occlusion system (EOS), to occlude the spermatic vein in symptomatic males with varicoceles.

Methods: The ArtVentive EOS device has been developed for percutaneous, peripheral occlusion of the peripheral arterial and venous vasculature. The system is comprised of an implantable occlusion device and a delivery catheter. At present, there are two device sizes: (a) size 1 for target vessels ranging between 3.5 and 5.5 mm in diameter, and (b) size 2 for target vessels 5.5-8.5 mm in diameter. The treatment group included six adult males, ages 22-34 years. Nine target vessels were occluded. A total of 20 devices were implanted in six subjects.

Results: The acute occlusion rate at the end of the procedure was 100 % occurring in nine of nine vessels. The spermatic veins of all patients remained occluded on venography at 30 days follow-up. Pain scores related to varicoceles decreased in five of six patients.

Conclusions: Although we recognize this study is limited, initial experience indicates that the ArtVentive EOS is a safe and effective new device for occlusion of vessels (varicoceles). The device has potential applications in other clinical conditions requiring occlusion of veins or arteries.