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.
- OSTI ID:
- 22318124
- Journal Information:
- Cardiovascular and Interventional Radiology, Vol. 37, Issue 1; Other Information: Copyright (c) 2014 Springer Science+Business Media New York and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE); http://www.springer-ny.com; This record replaces 46024321; Country of input: International Atomic Energy Agency (IAEA); ISSN 0174-1551
- Country of Publication:
- United States
- Language:
- English
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