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A New Occlusion Device: Application of the ArtVentive Endoluminal Occlusion System (EOS)- First in Human Clinical Trial


Venbrux, Anthony C; Rudakov, Leon; Plass, Andre; Emmert, Maximilian Y; Ebner, Adrian (2014). A New Occlusion Device: Application of the ArtVentive Endoluminal Occlusion System (EOS)- First in Human Clinical Trial. Cardiovascular and Interventional Radiology, 37(1):85-93.

Abstract

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.

Abstract

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.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Cardiovascular Surgery
Dewey Decimal Classification:610 Medicine & health
Language:German
Date:2014
Deposited On:17 Mar 2014 10:24
Last Modified:08 Dec 2017 03:32
Publisher:Springer
ISSN:0174-1551
Publisher DOI:https://doi.org/10.1007/s00270-013-0626-y
PubMed ID:23703667

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